NextStep® Retrograde Chronic Hemodialysis Catheter

Kits/Sets may not contain all accessory components detailed in these instructions for use. Become familiar with instructions for individual component(s) before beginning the procedure.

using fluoroscopy. Monitor patient for cardiac arrhythmia. 6. Dispose of needle.

SharpsAway® II Locking Disposal Cup (where provided):

A Suggested Procedure: Use Sterile Technique.

The SharpsAway II Locking Disposal Cup is used for disposal of needles (15 Ga. - 30 Ga.).

Prepare for Insertion:

•

Using one-handed technique, firmly push needles into disposal cup holes (refer to Figure 4).

•

Once placed into disposal cup, needles will be automatically secured in place so that they cannot be reused.

1. Identify appropriate vein for insertion. 2. Use direct visualization technologies, e.g., ultrasound or fluoroscopy, if available; and assess vein health. 3. Position patient as appropriate for insertion site.

Prep Puncture Site: 1. Prep puncture site with appropriate antiseptic agent. 2. Drape puncture site. 3. Identify appropriate venous insertion site and exit site by holding catheter in correct position over the patient’s chest. Appropriate catheter length is required to ensure that the catheter tip is within the right atrium to provide for optimal flow. Circumferential band is approximately 10 cm from proximal end of catheter and is the exit point. 4. Administer local anesthetic per institutional policies and procedures. 5. Securely attach irrigation tube to proximal end of catheter body. Flush each catheter lumen with sterile normal saline for injection, to establish patency and prime lumen(s) and flush the irrigation tube. 6. Flush hub connection assembly with sterile normal saline for injection and clamp extension lines to contain saline within lumen(s). NOTE: This preparation procedure step should be completed prior to access.

Figure 4

Precaution: Do not attempt to remove needles that have been placed into SharpsAway II Locking Disposal Cup. These needles are secured in place. Damage may occur to needles if they are forced out of disposal cup. 7. Enlarge cutaneous puncture site with cutting edge of scalpel positioned away from the guidewire to facilitate tissue dilator introduction. Warning: Do not cut guidewire to reduce risk of guidewire unraveling. • Engage safety and/or locking feature of scalpel (where provided) when not in use to reduce risk of sharps injury. 8. Carefully place 12 Fr. tissue dilator onto guidewire and advance to appropriate depth. A twisting motion may assist in advancing through tissue. 9. Repeat this procedure using 14 Fr. tissue dilator.

Precaution: Do not clamp any portion of catheter; clamp only irrigation tube with pinch clamp provided.

Recommended Retrograde Technique for New Insertion Sites Refer to Arrow Simplicity® Micro-Introducer Set instructions if using micro-puncture technique.

Warning: Do not over advance tissue dilator.

Gain Initial Vessel Access:

Warning: Do not leave tissue dilator in place as an indwelling catheter. Leaving tissue dilator in place puts patient at risk for possible vessel wall perforation.

1. Insert introducer needle into vein and aspirate. Warning: Pulsatile flow is usually an indicator of inadvertent arterial puncture.

Introduction Technique:

Precaution: Do not rely on blood aspirate color to indicate venous access.

SmartSeal™ Hemostatic Dialysis Sheath:

2. Verify proper needle placement using ultrasound (if available). 3. Remove syringe and cover Luer with thumb. 4. Advance guidewire through needle or micro-introducer sheath (where used) into vein.

The SmartSeal Hemostatic Dialysis Sheath permits insertion of chronic hemodialysis catheters with minimal bleed back and potential air embolism. Warning: Aspirate and saline flush the dilator prior to use. This step helps to reduce risk of air embolism and clot formation.

Warning: Do not advance guidewire or catheter if unusual resistance is encountered.

Warning: Do not leave peelable sheath in place as an IV access site.

Arrow Advancer:

Warning: Leaving guidewire in place after removing dilator may cause valve to leak.

Using thumb, straighten the “J” by retracting guidewire into Arrow Advancer (refer to Figures 2 and 3).

Warning: Inserted guidewire length is dependent upon patient’s anatomy. Verify placement using fluoroscopy. Monitor patient for cardiac arrhythmia. Precaution: This product is sensitive to light. Do not use if stored outside protective outer carton. Store in a cool, dark, and dry place. Precaution: Dilators and catheters should be removed slowly from sheath. Rapid removal may damage valve resulting in blood flow through valve. Never advance or withdraw guidewire or sheath when resistance is met. Determine cause by fluoroscopy and take remedial action. Precaution: Advance catheter quickly through valve to reduce risk of air embolism and blood loss through catheter’s side holes. Precaution: Some disinfectants used at the catheter insertion site contain solvents, which can attack the sheath material. Ensure insertion site is dry before placement.

Figure 2

Guidelines for SmartSeal Use: 1. Insert tissue dilator into sheath until dilator cap folds over valve housing and secures dilator onto sheath assembly. 2. Thread dilator/sheath assembly over guidewire. 3. Advance the dilator and sheath together with slight twisting motion over guidewire into vessel. 4. Confirm placement with fluoroscopy. Attaching a clamp or hemostat to proximal end of guidewire will minimize the risk of inadvertently advancing guidewire entirely into patient. 5. Separate dilator cap from sheath valve housing once the assembly is fully introduced into venous system. 6. Rock the dilator cap off hub while stabilizing sheath by grasping hub assembly (refer to Figure 5).

Figure 3

Alternate Technique: If a simple straightening tube is preferred, the straightening tube portion of Arrow Advancer can be disconnected from the unit and used separately. • Separate Arrow Advancer tip or straightening tube from blue Arrow Advancer unit. • Prepare for insertion by sliding plastic tube over “J” to straighten, if “J”Tip portion of guidewire is used. • Advance guidewire in routine fashion to desired depth. 5. Hold guidewire in place and remove introducer needle. Precaution: Do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire.

Figure 5 7. Remove clamp and slowly retract guidewire and dilator, leaving sheath in position. The hemostasis valve will reduce loss of blood and inadvertent aspiration of air through sheath. 8. Introduce catheter through hemostasis valve/sheath and advance to desired position. 9. Sharply snap the tabs of valve housing in a plane perpendicular to the long axis of sheath to split valve and split sheath apart while withdrawing from vessel (refer to Figure 6).

Precaution: Maintain firm grip on guidewire at all times. Keep sufficient guidewire length exposed for handling purposes. A non-controlled guidewire can lead to guidewire embolus. Precaution: Inserted guidewire length is dependent upon patient’s anatomy. Verify placement 2

Precaution: Ensure hub connection assembly cannula is fully seated into catheter and no cannula is visible. Failure to do so could compromise compression of catheter onto connector and catheter separation could occur. Precaution: Ensure extension line clamps are closed prior to catheter attachment. Warning: Green compression sleeve MUST be present when threading compression cap onto hub connection assembly. Failure to do so may result in air embolism, blood loss, or catheter separation. 7. Slide threaded compression cap over compression sleeve towards hub connection assembly with compression sleeve seated completely inside. 8. Thread compression cap onto hub connection assembly firmly, but do not over tighten. There should be no threads visible on hub connection assembly.

Figure 6

Precaution: Ensure compression sleeve is securely positioned inside threaded compression cap. Avoid attempts to place compression sleeve onto hub connection assembly cannula and then apply threaded compression cap. Incomplete compression may occur causing catheter separation.

10. Confirm catheter tip placement with fluoroscopy. 11. Continue with catheter insertion and sheath removal.

Recommended Catheter Tunneling Procedure:

1. Verify exit site. Circumferential band, approximately 10 cm from proximal end of catheter, is exit point. This allows adequate length of catheter to perform connection. 2. Administer local anesthetic to anesthetize anticipated tunnel tract tissue. 3. Create exit site; make a small incision on chest wall below clavicle approximately 6 cm lateral to venous insertion site.

9. Remove catheter clamp. 10. Attach syringes to extension line hubs and open clamps. Blood should aspirate without difficulty from both extension lines. 11. Reposition catheter to obtain adequate blood flows, if either extension line exhibits excessive resistance during blood aspiration. 12. Flush catheter thoroughly with sterile normal saline for injection to remove residual blood, posttreatment and before instilling heparin. 13. Inject designated priming volumes as indicated into appropriate lumens. Priming volumes are printed on extension line clamp inserts. In the event that catheter is cut other than at cut line, the priming volume is changed by 0.13 mL/cm of length change. 14. Inject heparin solution into each catheter lumen to ensure heparin completely fills catheter.

Warning: There is an increased risk of catheter related infections with femoral vein insertion. To decrease this risk, create exit site in pelvic region. 4. Using tunneling device, create a subcutaneous tunnel towards the venous insertion site. Catheter is marked to help locate exit site. Warning: Do not tunnel through muscle. The tunnel should be made with care in order to prevent damage to surrounding tissue.

Precaution: Ensure designated priming volumes are achieved.

5. Perform a small blunt dissection at venotomy toward exit site (this will minimize catheter kinking at venous insertion site).

15. Close extension clamps, remove syringes and place a Luer-Lock cap on each luer. • Keep extension lines clamped at all times when not in use to reduce risk of air embolism from occurring. • Aspirate and then irrigate catheter with sterile normal saline for injection prior to each use. 16. Purge air from catheter and all connecting tubing and caps with each change in tubing connections. 17. Assess placement of catheter tip in compliance with institutional policies and procedures.

Precaution: Do not over-expand subcutaneous tissue during tunneling. Over-expansion may prevent or delay cuff in-growth. Precaution: Do not create an excessively long tunnel; connection to hub connection assembly will be difficult. Six (6) cm length is ideal. 6. After tunneling device emerges from venous insertion site, use the tunnel dilator to expand the tract as needed to accommodate catheter cuff position. This expanded section should be approximately 4 cm in length or within 2 cm of exit site (cuff to circumferential band).

Precaution: Failure to verify catheter tip position may result in serious trauma or fatal complications. 18. Tape Luer-Lock caps and clamps securely to prevent inadvertent disconnection.

Warning: Do not pull tunneler out of the venous insertion site on an angle to prevent tissue damage; pull parallel to the body.

Precaution: Tape Luer-Lock caps and clamps between treatments to reduce risk of accidental opening of both, thereby, potentially causing blood loss and/or air embolism.

7. Clamp catheter then disconnect irrigation tube.

19. Tape connections of bloodlines during treatment to reduce risk of accidental disconnection. 20. Suture hub to skin using suture wing and apply dressing according to institutional policies and procedures.

Precaution: Catheter must be compressed closed with catheter clamp to prevent blood loss and air embolism. 8. Securely attach red connector of catheter to tunneler tip. Ensure parts are securely snapped together before pulling catheter through tunnel tract. Remove catheter clamp.

Care and Maintenance

9. Carefully pull tunneling device through the tract (laterally) until the catheter is clear of exit site.

Dressing:

Precaution: Do not create a sharp bend in catheter tunnel; kinking and reduced flow will result.

A transparent dressing should be used in accordance with manufacturer’s instructions for use. • Prepare site. Allow all preps to dry completely. • Peel liner from dressing to expose adhesive. • Place without tension over insertion site. Slowly remove frame while smoothing down dressing edges (refer to Figure 8).

Warning: Do not forcefully pull tunneler and catheter apart; catheter breakage may occur. Precaution: Ensure catheter is not twisted during tunneling since this may result in catheter occlusion.

Complete Catheter Insertion

1. Once catheter is pulled through tunnel, check that proximal circumferential mark is close to exit site. Use exit site mark on catheter to ensure that cuff is positioned properly. 2. Slide threaded compression cap and compression sleeve (pre-loaded on tunneler handle) onto catheter and beyond cut mark. 3. Wet compression sleeve with saline to slide components freely over catheter. 4. Clamp catheter immediately proximal to catheter exit site mark. Precaution: Catheter must be compressed closed with catheter clamp to prevent blood loss and air embolism. Precaution: Orient the catheter so the scissor symbol is facing up. This will permit accurate clamping/cutting of catheter.

Figure 8

5. Cut catheter at cut-indication mark.

•

Precaution: Ensure 6 cm of exposed catheter remains proximal to exit site line. Remaining recommended catheter length facilitates catheter repair should extension line damage occur over time (refer to Figure 7). Exit Site Arterial (red) Venous (blue)

Exit Site Care:

Alcohol, alcohol-based solutions (e.g. Hibiclens, Chloraprep), iodine-based solutions (Povidone-Iodine), PEG-based ointments (e.g., Bactroban®), hydrogen peroxide, or ExSept Plus are accepted for use with this catheter at the exit site (including the juncture hub and catheter body). Ensure that solution is completely dry before applying an occlusive dressing. Warning: Avoid excessive or prolonged use of alcohol-based solutions and ointments to clean catheter or site care. • Clean skin around catheter using acceptable skin antiseptics. • Cover exit site with sterile occlusive dressing for the entire duration of implantation. If catheter swelling is observed, discontinue use and replace catheter. • Exit site and dressings must be kept clean and dry.

Cuff

Tunneled Catheter

Catheter Body

(cut)

Label dressing according to protocol. Refer to individual manufacturer’s instructions for more information and specific detailed instructions for dressing removal (not included).

Ensure 6 cm of exposed catheter remain

Extension Line Assembly Care:

Figure 7

Alcohol, alcohol-based solutions (e.g. Hibiclens, Chloraprep) and iodine-based solutions (Povidone-Iodine) are accepted for use with the extension line assemblies (including luer hubs, extension lines, and clamps).

6. Insert hub connection assembly cannula into lumens of catheter at a 45° angle. Make sure to have extension lines closed.

Infection:

Precaution: Orient catheter lumen prior to connection; blue printed side of catheter is connected to line with blue extension line clamp and side with red printing with red extension line clamp.

It may become necessary to exchange the indwelling catheter due to infection. Follow institutional protocol. 3

Catheter Patency:

NOTE: Figure 9 is based on in vitro testing of the 23 cm length catheter. Testing was performed using a 2:3 glycerin/deionized water solution with a viscosity of 3.2-3.5 cP at 37⁰C.

•

Establish and maintain catheter patency. Solution and frequency of flushing a venous access catheter should be established in hospital/institutional policy. • Volume of flush solution should be equal to the priming volume of the catheter. NOTE: Priming volumes are printed on extension line clamp inserts.

Recommended Flow Rate and Pressure Range for Catheters Intended for Femoral Insertion:

Heparinization: • • •

To maintain patency of catheter between treatments, a heparin-lock must be created in each lumen of catheter. Concentration of heparin used and flush frequency should be determined by hospital protocol. Properly cleanse all connectors with an appropriate antiseptic before being accessed. Open catheter clamp prior to infusion through lumen. Properly flush (heparinization) using a positive-pressure flushing technique to help prevent occlusion.

150

Management of One-Way Obstructions:

One-way obstructions exist when a lumen can be flushed easily, but blood cannot be aspirated. This is usually caused by tip malposition. One of the following adjustments may resolve obstruction: • reposition catheter • reposition patient • have patient cough • Provided there is no resistance, flush catheter vigorously with sterile normal saline for injection to try to move tip away from vessel wall.

Pressure (mmHg)

200

250

Flow Rate (mL/min)

300

350

The forward and reverse recirculation rates for the NextStep Retrograde Catheter are 0.3% and 1.3% respectively.

For reference literature concerning patient assessment, clinician education, insertion technique, and potential complications associated with this procedure, consult standard textbooks, medical literature, and Arrow International LLC website: www.teleflex.com A pdf copy of this IFU is located at www.teleflex.com/IFU

150 100

Venous Arterial

-100 -150 -200 400

150

Figure 10

Pressure Versus Flow

300

100

NOTE: Figure 10 is based on in vitro testing of the 55 cm length catheter. Testing was performed using a 2:3 glycerin/deionized water solution with a viscosity of 3.2-3.5 cP at 37⁰C.

Recommended Flow Rate and Pressure Range for Catheters Intended for Internal Jugular and Subclavian Insertion:

200

-50

-300

Catheter Performance

-250

Arterial

-250

1. Follow catheter removal instructions, Steps 1-8. Precaution: Be careful not to cut catheter. 2. Under fluoroscopy, using the Arrow Advancer, advance guidewire through existing catheter’s distal lumen until the tip of the guidewire lies at the desired position. 3. Remove the existing catheter over the guidewire. During removal, be careful to leave the guidewire in place. Precaution: Maintain firm grip on guidewire at all times. Keep sufficient guidewire length exposed for handling purposes. A non-controlled guidewire can lead to guidewire embolus. 4. Apply gentle digital compression at venotomy site once the exchanged catheter has been removed to minimize blood loss, hematoma and risk of air embolism. 5. Check catheter integrity for tears. Measure catheter when removed; it must be equal to length of catheter when inserted. Inspect for presence of entire cuff. 6. For proper catheter tip placement, ensure appropriate exchange catheter length is selected. 7. Flush the lumens of replacement catheter with sterile normal saline for injection and clamp the extension line of the proximal lumen. 8. Under fluoroscopy, advance the catheter over the guidewire until the tip is in the desired position. 9. Slowly remove the guidewire while maintaining catheter tip position and immediately clamp the lumen. Precaution: Failure to verify catheter tip position may result in serious trauma or fatal complications. 10. Follow institutional policies and procedures (as appropriate): • Verify catheter patency and flow. Flush with sterile normal saline for injection and “lock” with heparin. • Implement wound hemostasis, closure, and site dressing. • Document catheter exchange procedure on patient’s chart. NOTE: Refer to procedures for details of catheter insertion and removal techniques.

-50

Venous

0

-200

Recommended Retrograde Technique for Over-the-Wire Exchanges

0

50

-150

1. Place patient in supine position, as clinically indicated to reduce risk of potential air embolism. 2. Remove dressing. Warning: Do not use scissors to remove dressing to reduce risk of cutting catheter. 3. Palpate along catheter tunnel tract to locate cuff. 4. Anesthetize catheter exit and cuff sites. 5. Remove all sutures used to secure catheter, per hospital protocol. 6. Using blunt dissection, dissect around catheter exit site and cuff while maintaining traction on the catheter. Precaution: Be careful not to cut catheter. 7. Make a small incision, as needed, along length of catheter starting at cuff site. 8. Using blunt dissection, dissect down cuff at small incision. 9. When visible, clamp catheter between cuff and exit site. 10. Cut catheter between clamp and exit site, remove internal portion of catheter through cuff incision site. 11. Check catheter integrity for tears. Measure catheter when removed; it must be equal to length of catheter when inserted. 12. Remove other catheter section through catheter exit site. 13. Follow hospital protocol for wound hemostasis and closure. 14. Dress insertion site. 15. Document catheter removal procedure including confirmation that entire catheter length (including entire cuff and tip) has been removed per institutional policies and procedures.

50

100

-100

Catheter Removal Instructions

200

Pressure Versus Flow

200

Pressure (mmHg)

•

500

Flow Rate (mL/min) Figure 9

4

Symbol Glossary: Symbols are in compliance with ISO 15223-1 unless indicated with an *. Some symbols may not apply to this product. Refer to product labeling for symbols that apply specifically to this product.

Caution

Medical device

Consult instructions for use

Do not reuse

Do not resterilize

* 20°C (68°F)

Keep away from sunlight

Keep dry

Do not use if package is damaged

Not made with natural rubber latex

25°C (77°F)

Store between 20°C (68°F) - 25°C (77°F)

Sterilized by ethylene oxide

Single sterile barrier system with protective packaging inside

*

*

MR Conditional

Dialysis patient identification

Catalogue number

Single sterile barrier system

Lot number

Arrow, the Arrow logo, NextStep, SharpsAway, SmartSeal, Teleflex and the Teleflex logo are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. © 2021 Teleflex Incorporated. All rights reserved. Use by

Manufacturer

Date of manufacture

Arrow International LLC Subsidiary of Teleflex Incorporated 3015 Carrington Mill Blvd., Morrisville, NC 27560 USA USA: 1 866 246 6990 | International: +1 919 544 8000

Q-15232-109B (2021-03) 6