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 Implantable Ports with PASV Valves are indicated for use in patients who require long-term access to the central venous system for administration of fluids including but not limited to, hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal.

Contraindications

The device is contraindicated when:

• The presence of other device related infection, bacteremia, septicemia or peritonitis is known or suspected.
• Severe chronic obstructive lung disease exists.
• Past irradiation of prospective insertion site.
• Previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site.
• Local tissue factors will prevent proper device stabilization and/or access.
• Anticipation or presence of other central venous intraluminal devices, including pacemakers, is expected.
• Hypercoagulopathy condition exists, unless considerations are made to place the patient on anticoagulation therapy.
• Presence or suspicion of allergic reaction to materials contained in this device is a potential risk.
• Body size is insufficient to accommodate size of the portal or the catheter.
• Demonstrated intolerance for an implanted device.

Venous access to the upper torso may be contraindicated due to anatomical constraints, such as burns to the upper body, cervicothoracic trauma, planned radiation therapy to the mediastinum, bilateral neck dissection and infected median sternotomy incisions.

Warnings

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

For single 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 or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

Due to the risk of exposure to HIV (Human Immunodeficiency Virus) or other blood borne pathogens, health care workers should routinely use universal blood and bodyfluid precautions in the care of all patients. Sterile technique must be strictly adhered to during any handling of the device.

Potential Adverse Effects

Although the Vaxcel Implantable Ports with PASV Valves have been engineered for optimal safety, there are inherent risks associated with any implantable device. These include the following:

• Air or catheter embolism
• Arteriovenous fistula
• Bacteremia
• Bleeding
• Brachial plexus injury
• Cardiac arrhythmia
• Cardiac tamponade
• Catheter or port erosion through skin/vessel
• Catheter occlusion, malposition, dislodgment, fragmentation, migration, disconnection, or rupture
• Catheter occlusion or breakage caused by pinching between clavicle and first rib
• Death
• Catheter thrombosis
• Drug extravasation
• Embolism of catheter fragments
• Endocarditis
• Implantation site necrosis or infection
• Fibrin sheath formation
• Hematoma
• Hemothorax
• Hydrothorax
• Inflammation
• Infection
• Implant rejection
• Implant rotation or extrusion
• Laceration or perforation of vessel
• Pneumothorax
• Thoracic duct injury
• Thromboembolism
• Thrombophlebitis
• Vascular thrombosis
• Nerve damage
• Tunnel infection
• Risks normally associated with local and general anesthesia, surgery, and post-operative recovery

Cautions

Avoid handling the catheters with sharp objects. Silicone rubber may be easily cut or torn. When handling the catheter, padded hemostats, vascular clamps, or tube occluding forceps should be used. INSTRUMENTS WITH TEETH SHOULD NEVER BE USED TO GRASP THE CATHETER. DAMAGING THE CATHETER PRIOR TO OR DURING INSERTION MAY CAUSE CATHETER FRACTURE IN THE VESSEL. The catheter should only be grasped at the end that will be trimmed prior to insertion.