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Vaxcel® Plus Cateter para Diálise

Navilyst | Critical Care | Cateter Diálise Cronica
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Descrição

The Vaxcel® Plus Catheter technology enhances durability and improves ease of care. With a product design that facilitates placement, promotes high blood flow and enhances catheter security, the Vaxcel® Plus Chronic Dialysis Catheter is designed to provide for excellent patient care.

- The tapered Carbothane® Material Catheter Extrusion of Vaxcel® Plus Dialysis Catheter is an alcohol-resistant material designed to provide biocompatibility, durability, flexibility and ease of care. It is designed to facilitate placement, improve kink resistance and reduce the need for catheter manipulation and replacement.

- The enhanced polyester cuff design has a longer cuff area, providing increased surface area. It is designed to enhance placement security and reduce the risk of dislodgment.

- The 14.5 Fr shaft combines excellent materials and engineering, and is designed to provide flow vs. pressure characteristics that enhance patient comfort and improve dialysis efficiency.

- Printed hubs reference product name and catheter length, as well as priming volume, which facilitates care and maintenance.

- The tapered, round single shaft is designed to allow an easier insertion than oval, dual or split catheters.

- Staggered lumen tips are designed to separate inflow from outflow, reducing recirculation risk.

- The thin-walled, double-D polyurethane extrusion is designed to improve the cross-sectional area, as well as bloodflow.

- The Vaxcel® Plus Chronic Dialysis Catheter is conveniently packaged, organizing equipment in an accessible tray. Options include a catheter tray, or a full kit tray that contains a safety needle and a safety scalpel.

- A range of catheter lengths provides the ability to meet various anatomical requirements.

Additional Information
*Data from Navilyst Medical performance testing on file, Navilyst Medical

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.

Placement of a Dialysis Catheter

For a patient whose kidneys have failed, venous access, or access to the blood system, must be established and maintained for dialysis treatments. Placement of a chronic dialysis catheter (CDC) can provide this access. CDCs have an opening (arterial port) for blood flow out of the body and another opening (venous port) for blood return after it flows through the dialysis machine. These catheters are usually inserted in the chest or neck.

See Prescriptive Information regarding specific Navilyst Medical product indications, contraindications, precautions and warnings. Please refer to Directions for Use for more complete information.

Dialysis Catheter: General Placement
The procedure described here is a general overview of the placement of a dialysis catheter. Strict aseptic technique must be used during insertion procedure.

Chronic dialysis catheters (CDCs) are cuffed, tunneled catheters. The configuration is dual-lumen, with an arterial port for blood flow out of the body, and a venous port for blood return after flow through the dialysate. Risk of recirculation of blood is decreased by a staggered tip design.

Flow rate is an important consideration in tunneled CDC design, as faster flow rates decrease dialysis time for the patient.

Dialysis Catheter: Typical Access Sites
Generally, for tunneled CDCs, the preferred veins for central access are the right internal jugular (RIJ), right external jugular (REJ), left internal jugular (LIJ), left external jugular (LEJ)—in that order.1

The National Kidney Foundation’s Kidney Disease Outcomes Quality Initiative Clinical Practice Guidelines for Hemodialysis Adequacy (K/DOQI Guidelines) state that subclavian vein (SCV) catheterization should be avoided in patients with end stage renal disease (ESRD) because of the risk for central venous stenosis, with subsequent loss of the entire ipsilateral arm for vascular access.

The tunnel for the CDC is created by advancement of a tunneling device through the subcutaneous tissue on the chest wall. The tunnel may be placed medially, with the exit site at a parasternal infraclavicular location. Alternately, it may be placed laterally, with the exit site below the clavicle at the deltopectoral groove.

The cuff of the tunneled CDC acts to hold the catheter in place. In addition, it is designed to cause a fibrotic reaction, creating a physical barrier to bacteria that prevents bacterial migration and inoculation via the exit site. The cuff is positioned within the tunnel at a distance from the exit site that will facilitate removal.

1. Kaufman JA, Lee MJ. Vascular and Interventional Radiology. The Requisites. Philadelphia, PA: Mosby; 2004.

National Kidney Foundation is a registered trademark of National Kidney Foundation Corporation.

Resources
Vaxcel Plus Chronic Dialysis Catheter

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