EXPO™ Diagnostic Catheter

Prescriptive Information

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE

Boston Scientific Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.

CONTRAINDICATIONS

None known.

WARNINGS

Do not exceed the pressure ratings printed on the label.

Catheter integrity may be compromised if the pressure exceeds the maximum pressure listed.

PRECAUTIONS

Angiographic catheters are designed for use by physicians engaged in the practice of a specialized branch of medicine. Use of these devices should be restricted to those specialists trained to perform the procedure. A thorough understanding of the technical principles, clinical applications and risks associated with angiography is necessary before performing this procedure.

Use prior to the “Use By” date.

Rotate inventory to maintain fresh stock.

To avoid damaging the tip of the catheter during removal from the package, open as follows: Grasp the hub and slowly withdraw the catheter. Rapid removal may result in damage to the catheter tip. Do not use if catheter is kinked or tip is damaged.

Carefully inspect the catheter prior to use to verify the size and shape as suitable for the specific procedure and that it has not been damaged during handling.

Angiographic catheters should only be manipulated while under fluoroscopic observation.

To facilitate its introduction and avoid damage at the puncture site, the angiographic catheter should be introduced using a guidewire.

Precautions to prevent or reduce clotting should be taken when any catheter is used. While in the vascular system, the catheter should always be filled with either flushing solution or contrast medium. Use of systemic heparinization should be considered.

ADVERSE EVENTS

Potential adverse reactions which may result from the use of this device include but are not limited to:

• Access site pain
• Allergic and neurological reactions
• Arrhythmia
• Death
• Hemorrhage or hematoma
• Impaired blood flow due to thrombosis, embolism, or vasospasm that could lead to myocardial infarction, stroke, transient ischemic attack (TIA), limb amputation, and other thrombo-embolic organ damages such as renal infarction
• Infection
• Organ failure
• Vessel trauma

In addition, the use of contrast may cause renal failure or other adverse reactions.