Imager™ II Angiographic Catheter

Prescriptive Information

Indications

The Imager II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system.

Contraindications

No known contraindications.

Warnings

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 diagnostic angiography is necessary before performing this procedure. Accordingly, the Imager II Angiographic Catheters should only be used by physicians with a thorough understanding of angiographic procedures.

Due to the various sizes and shapes, relative stiffness of angiographic catheters, extreme care must be taken when selecting and using the Imager II Angiographic Catheters to avoid damage to the vessel walls through which this catheter passes.

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 or 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.

Do not exceed the pressure ratings printed on the device labeling. Catheter integrity may be compromised if pressure limits are exceeded.

The risk associated with Imager II Angiographic Catheters outside the intended use is not known.

Potential Adverse Effects

The following adverse events have been reported and are associated with the use of angiographic catheters:

• Thrombus formation
• Emboli
• Arterial Wall Damage
• Plaque Dislodgment
• Hematoma
• Cardiac arrhythmias
• Myocardial Infarction
• Stroke
• Death

Cautions

• Carefully inspect the catheter prior to use to verify the size and shape are suitable for the specified procedure and that no damage has occurred during shipment.
• Extreme care must be taken when selecting and using the Imager II Angiographic Catheters to avoid damage to the vessel walls through which this catheter passes.
• Do not use opened or damaged packages.
• Use prior to the "Use By date".
• Non-pyrogenic.
• Store in a dry, dark, cool place.
• To facilitate the introduction of the catheter and avoid damage to the puncture site, the catheter should be introduced through an introducer sheath and over an appropriate guidewire.
• The Imager II Angiographic Catheters are designed for use with specific guidewire diameters. The recommended maximum guidewire diameter is provided on the catheter label.
• Guidewire use has been associated with a higher incidence of thrombus formation. Optimal guidewire diameter and judicious use are recommended.
• Precautions to prevent or reduce clotting should be taken when any catheter is used in the vascular system, the catheter should always be filled with either flushing solution or contrast medium. Use of systemic heparinization should be considered.
• If resistance is encountered during catheter manipulation, determine the cause under fluoroscopy and take the necessary remedial action.
• If resistance is encountered when removing the guidewire from the catheter, simultaneously remove the catheter and the guidewire as a single unit under fluoroscopy to prevent potential damage to the vessel and/or product damage.
• Any use of these devices other than those indicated in the instructions is not recommended.

Trademark

Imager II is a trademark of Boston Scientific Corporation or its affiliates.