Indications For Use
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
Refer to the Instructions for Use for complete instructions for use.
Indications
The Vaxcel Plus Chronic Dialysis Catheter is designed for chronic hemodialysis and apheresis. Catheter lengths of 37cm and 50cm are indicated for femoral vein insertion.
Contraindications
The device is contraindicated when:
- The presence of other device related infection, bacteremia, or septicemia is known or suspected;
- Severe chronic obstructive lung disease exists;
- Past irradiation of prospective insertion site has occurred;
- Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site have occurred;
- Local tissue factors will prevent proper device stabilization and/or access.
Warnings
Due to the risk of exposure to HIV (Human Immunodeficiency Virus) or other blood born pathogens, healthcare workers should routinely use universal blood and body-fluid precautions in the care of all patients.
- To avoid air embolism, keep the catheter clamped at all times when not attached to syringes or blood lines.
- Do not use acetone or any part of the catheter tubing. Exposure to this agent may cause catheter damage.
- The Vaxcel Plus Chronic Dialysis Catheter should be used with caution and only after careful consideration in patients who are at risk of bleeding complications.
Potential Adverse Effects
- Air embolism
- Perforation of vessel
- Hemorrhage
- Endocarditis
- Bacteremia
- Pneumothorax
- Hemothorax
- Exit site infection
- Bleeding
- Subcutaneous hemotoma
- Inflammation
- Exit site necrosis
- Brachial plexus injury
- Thoracic duct injury
- Femoral nurve injury
- Femoral artery laceration
- Fibrin sheath formation
- Cardiac arrhythmia
- Tunnel infection
- Luminar thrombosis
- Hematoma
- Cardiac tamponade
- Vascular thrombosis
- Death
Cautions
- If catheter and components show any sign of damage (crimped, crushed, cut, etc.) do not use.
- If using an introducer sheath other than the on provided, verify that the catheter fits easily through the introducer sheath.
- Do not use sharp instruments near the extension tubes or catheter shaft.
- Do not use scissors to remove the dressing, as this could possibly cut or damage the catheter.
- Do not suture through any part of the catheter. If sutures are used to secure the catheter, make sure they do not occlude or cut the catheter.
- Catheter tubing can tear when subjected to excessive force or rough edges.
- Avoid sharp or acute angles during implantation that could compromise catheter functionality.
- Fill (prime) the device with sterile heparinized saline or normal saline solution to help avoid air embolism prior to catheter insertion.
- Excessive force should not be used to flush obstructed lumen. Do not use a smaller syringe than 10mL.
- Tape injection caps (or other type used) between treatments to safeguard them against accidental removal
- It is recommended that only luer lock (threaded) accessories and components be used with the Vaxcel Plus Chronic Dialysis Catheter. Repeated over tightening of bloodlines, syringes, and caps will reduce connector life and could lead to potential connector failure. Inspect the catheter frequently for nicks, scrapes, cuts, etc. that could impair its performance.
- Clamping the extension tubes repeatedly in the same spot could weaken the tubing. Change the position of the clamp regularly to prolong the life of the tubing.
- Avoid clamping near the adapter and hub of the catheter. Do not clamp the shaft of the catheter. Use only the line extension clamps that have been provided with the catheter.
- Examine tubing for damage at the end of each treatment.
- It is not recommended to insert the Vaxcel Plus Chronic Dialysis Catheter through a previously stented vessel, as the catheter may dislodge the stent, causing it to migrate.
Trademark
Carbothane is a trademark of Noveon IP Holdings Corp.
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