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 with PASV^® Valve Technology is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal.

This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.

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
• Inadequate antecubital veins
• Pre-existing skin surface or subsurface infection at or near the proposed catheter insertion site
• Anatomical distortions from surgery, injury or trauma
• Anatomical irregularities (structural or vascular) which may compromise catheter insertion or catheter care procedures

Warnings

Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found call your Boston Scientific representative.

For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing and resterilization may also create a risk of contamination of the device and/or cause patient infection or crossinfection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

LATEX: This product contains No Detectable Latex.

Due to the risk of exposure to HIV (Human Immunodeficiency Virus) and/or other bloodborne pathogens, health care 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.
• Prior to dressing the catheter and access site, inspect both to assure that they are completely dry of isopropyl alcohol or acetone based cleansing agents. To avoid pooling of an agent, do not fully insert catheter up to suture wing.
• Do not use the catheter with chemicals that are incompatible with any of its components, as catheter damage may occur.

Potential Adverse Effects

• Air Embolism
• Bacteremia
• Bleeding
• Brachial Plexus Injury
• Cardiac Arrhythmia
• Cardiac Puncture
• Cardiac Tamponade
• Catheter Erosion Through Skin/Vessel
• Catheter Fragmentation
• Catheter Migration
• Catheter Occlusion
• Catheter Rupture
• Death
• Drug Extravasation
• Drug Precipitate
• Embolism of Catheter Fragments
• Endocarditis
• Exit Site Infection
• Exit Site Necrosis
• Fibrin Sheath Formation
• Foreign Body Rejection
• Hematoma
• Hemorrhage
• Hemothorax
• Inflammation/Phlebitis
• Laceration of Vessel
• Luminar Thrombosis
• Nerve Damage
• Perforation of Vessel
• Pneumothorax
• Subcutaneous Hematoma
• Thoracic Duct Injury
• Thromboembolism
• Thrombophlebitis
• Vascular Thrombosis

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 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 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, 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.
• Excessive force should not be used to flush an obstructed lumen. Do not use smaller than a 10 mL syringe.
• 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 with PASV^® Valve. Repeated over-tightening may reduce hub connector life.
• Do not attempt to repair the 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.
• Use of a needle to access the catheter is not necessary. However, if a needle is used, do not use a needle longer than 1.9cm, as it may cause damage to the valve.
• Do not place the catheter into the right atrium or the right ventricle of the heart.
• Catheter tip location needs to be verified. It is recommended to use radiographic visualization. Patient movement may 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.
• Do not reinsert the introducer needle into the peelable sheath, as this may cause damage to the sheath.
• 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 to remove the catheter may lead to catheter separation. Hold the catheter distal to the suture wing during removal.
• The health care 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.