The Vaxcel® PICC is a non-valved catheter intended for short- or long-term infusion therapy. It is available in a variety of configurations to satisfy the needs of the inserter.

- Vaxcel® PICCs are designed for image-guided placement.  Enhanced radiopacity is designed for improved visualization when using fluoroscopic guidance for insertion and for tip confirmation via chest x-ray.
- Vaxcel® PICCs incorporate a reverse taper extrusion, which is designed for improved kink resistance.  In addition, the reverse taper is intended to provide greater pushability for easier placement.
- The catheter body’s large lumen diameters are designed to provide greater flow rates at lower pressures and minimize the risk of catheter occlusion. 
- Users may also benefit from the clear extension tubes offered by the Vaxcel® PICC design.  These are intended to provide early visualization of blood return.

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® PICC catheter system is designed for use when central venous catheterization or prolonged intravenous administration of fluids, medications, and/or nutritional therapy is prescribed.

A variety of insertion sites may be utilized, depending upon the patient involved and the catheter size selected. While any vessel suitable for insertion may be used, the basilic vein is the most commonly used vein. Location of the distal catheter tip must provide maximum dilution for whatever therapy becomes necessary and assurance of a continued, uncompromised vascular access.

Contraindications

- Venous thrombosis in all or any portion of the vein where the catheter is expected to reside.
- Conditions that impede venous return from the extremity such as paralysis or lymphedema after mastectomy.
- Orthopedic or neurological conditions affecting the extremity.
- Anticipation or presence of dialysis grafts or other intraluminal devices such as pacemakers.
- Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy.

Warnings

- This product contains no detectable latex.
- Due to the risk of exposure to HIV (Human Immunodeficiency Virus) and/or other bloodborne pathogens, healthcare workers should routinely use universal blood and body fluid precautions in the care of all patients. Sterile technique must be strictly adhered to during any handling of the device.
- Do not resheath any needles. Place needles in puncture resistant, leak proof, sharps containers per institutional protocol.
- If using bacteriostatic saline, do not exceed 30 mL in a 24-hour period.
- Do not use acetone or alcohol-based iodine solutions on any part of the catheter tubing. Exposure to these agents may cause catheter damage. Aqueous-based povidone iodine is recommended for site care.
- Do not use the catheter with chemicals that are incompatible with any of its components, as catheter damage may occur.

Precautions

- If catheter and components show any sign of damage, do not use.
- If using an introducer sheath other than the one provided, verify that the catheter fits easily through the sheath.
- Do not use sharp instruments near the extension tubes or catheter shaft.
- Do not use scissors to remove the dressing, as this may possibly 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, puncture, or cut the catheter. Catheter tubing can tear when subjected to excessive force or rough edges.
- Avoid sharp or acute angles during insertion which may compromise catheter functionality.
- Do not use smaller than a 10 mL syringe when attempting to flush, or administer medications through the catheter.
- Do not exceed 40 psi/276 kPa (207 cmHg) on infusion pumps when administering fluids.
- Incompatible drug delivery within the same lumen may cause precipitation. Ensure that the catheter lumen is flushed following each infusion.
- It is recommended that only Luer lock accessories and components be used with the Vaxcel® PICC. Repeated over-tightening may reduce hub connector life.
- Do not attempt to repair catheter. If breaks or leaks are apparent in the catheter, replace the entire catheter.
- Do not use hemostats to secure Luer lock hub connections.
- Do not use clamps, ribbed forceps, or other instruments to advance or position catheter. Use non-serrated forceps only.
- Catheter removal is to be undertaken only by trained personnel.
- Exercise care when advancing the catheter to avoid trauma to the vessel intima.
- Apply a sterile end cap on the catheter hub to prevent contamination when not in use.
- Catheter tip location needs to be verified. It is recommended to use radiographic visualization. Patient movement can cause catheter tip displacement.
- Do not clamp the catheter or extension tube while the stiffening wire or guidewire is inside the catheter, as this may damage the catheter.
- Avoid blood pressure measurement or the application of a tourniquet to the catheterized arm, since catheter occlusion or other damage to the catheter may occur.
- Use of force when removing the catheter may lead to catheter separation. Hold the catheter distal to the suture wing during removal.
- Remove catheter immediately upon confirmation of catheter damage.
- The healthcare provider is responsible for all patient instructions regarding catheter care and maintenance.
- Avoid pressure on the inner surface area or axilla of the
- cannulated arm while using crutches.
- Do not insert the blunt end of the guidewire into the vein.
- Following institutional policy, secure catheter externally to prevent catheter movement, migration, damage, kinking or occlusion.

Adverse Events

- Air Embolism
- Artery or Vein Puncture
- Arteriovenous Fistula
- Brachial Plexus Injury
- Cardiac Arrhythmia
- Cardiac Puncture
- Cardiac Tamponade
- Cardiac Fragmentation
- Catheter Occlusion
- Catheter Rupture
- Drug Extravasation
- Embolism of Catheter Fragments
- Endocarditis
- Erosion of Catheter through Skin and/or Blood Vessel
- Fibrin Sheath Formation at Catheter Tip
- Foreign Body Rejection
- Hematoma and Catheter Related Sepsis
- Hemothorax
- Incompatible Drug Prescription resulting in Solid Precipitate
- Infection/Bacteremia/Sepsis
- Migration of Catheter
- Peripheral Nerve Damage
- Pneumothorax
- Thoracic Duct Injury
- Thromboembolism
- Thrombophlebitis
- Thrombosis
- Risks Normally Associated with Local and General Anesthesia, Surgery and Post-Operative Recovery

These and other complications are well documented in the medical literature and should be carefully considered before placing the catheter. Placement and care of the Vaxcel® PICC should only be performed by persons knowledgeable of the risks involved and qualified in the procedures.