Teleflex Medical

NextStep® Antegrade Chronic Hemodialysis Catheter

4 Pages

NextStep® Antegrade Chronic Hemodialysis Catheter Rx only.  Product Description  7. Clinicians must be aware of potential entrapment of the guidewire by any implanted device in circulatory system. It is recommended that if patient has a circulatory system implant, catheter procedure be done under direct visualization to reduce risk of guidewire entrapment.  The Arrow® NextStep® Antegrade consists of a catheter with a dual lumen radiopaque polyurethane body, step-tip configuration, and 6 cm spacing between two ports. This catheter is first tunneled antegrade to venous insertion site, followed by vessel access and tip placement (refer to Figure 1).  8. Passage of guidewire into the right heart can cause dysrhythmias, right bundle branch block, and a perforation of vessel, atrial or ventricular wall.  The Arrow® NextStep® Antegrade Catheter is manufactured from radiopaque polyurethane.  Extension Lines Arterial Port  9. Do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage.  Extension Line Clamps  Luer Connections  10. Patients requiring ventilator support are at an increased risk of pneumothorax during subclavian vein cannulation. 11. Extended use of subclavian vein may be associated with subclavian vein stenosis.  Juncture Hub  12. Clinicians must be aware of complications/undesirable side-effects associated with central venous catheters including, but not limited to: • laceration of vessel • air embolus • bacteremia • lumen thrombosis • brachial plexus injury • mediastinal injury • caval perforation w/bronchial • puncture/perforation of vessel communication • pleural injury • cardiac arrhythmia • pneumothorax • cardiac tamponade • retroperitoneal bleed • central venous thrombosis • right atrial puncture • endocarditis • septicemia • exit site infection • thoracic duct laceration • exsanguination • tunnel infection • femoral nerve damage • vascular thrombosis • hematoma • venous stenosis • hemorrhage • subcutaneous hematoma • hemothorax  Venous Port  Cuff  Figure 1  Indications for use: The Arrow NextStep Antegrade Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow NextStep Antegrade Catheter is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Arrow NextStep Antegrade Catheter is intended for use in adult patients.  Precautions:  Contraindications:  3. Use standard precautions and follow institutional policies for all procedures including safe disposal of devices.  1. Do not alter any kit/set component during insertions, use or removal (except as instructed). 2. Procedure must be performed by trained personnel well versed in anatomical landmarks, safe technique and potential complications.  The Arrow NextStep Antegrade Catheter is intended for long-term hemodialysis vascular access only and should not be used for any other purpose other than those indicated herein. Do not use this catheter in patients with thrombosed vessels.  4. Examine catheter and extension lines before and after each treatment for any signs of damage. 5. Do not use acetone with this catheter or catheter degradation may occur.  Clinical Benefits to be Expected: • • • •  Permits long term vascular access for hemodialysis and apheresis. Permits vascular access percutaneously. Permits vascular access by way of the internal jugular, subclavian veins. Catheters greater than 40 cm permit vascular access by way of the femoral veins.  6. Do not use sharp instruments near extension lines or catheter. 7. Do not use clamps other than those that are provided. Using other clamps may damage the catheter. 8. Do not clamp tubing repeatedly in the same place. Doing so may weaken the tubing.  General Warnings and Precautions Warnings:  9. Avoid clamping near Luer-Lock fittings.  1. Sterile, Single use: Do not reuse, reprocess or resterilize. Reuse of device creates a potential risk of serious injury and/or infection which may lead to death. Reprocessing of medical devices intended for single use only may result in degraded performance or a loss of functionality.  10. Repeated over tightening of bloodlines, syringes and caps will reduce connector life and could lead to potential connector failure. 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.  2. Read all package insert warnings, precautions and instructions prior to use. Failure to do so may result in severe patient injury or death. 3. All chronic dialysis catheters should be used only as bridge devices and are not intended for extended use unless no other hemodialysis access options exist.  A Suggested Procedure: Use Sterile Technique. Prepare for Insertion:  4. Air embolism can occur if air is allowed to enter a vascular access device or vein. Do not leave open needles or uncapped, unclamped catheters in venous puncture site. Use only securely tightened LuerLock connections with any vascular access device to guard against inadvertent disconnection.  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:  5. Do not apply excessive force in placing or removing catheter or guidewire. Excessive force can cause component damage or breakage. If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested.  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. 4. Administer local anesthetic per institutional policies and procedures.  6. If guidewire becomes damaged, catheter and guidewire must be removed together. 1
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