Imager™ II Angiographic Catheter

INTENDED USE/INDICATIONS FOR USE

The Imager II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the peripheral vascular system. Additionally, the Imager II Angiographic Catheters can also be used for the controlled and selective delivery of the Boston Scientific Interlock - 35 Detachable Coils into the peripheral vasculature.

CONTRAINDICATIONS

No known contraindications.

WARNINGS

• Do not store this product in an area that is subject to aggressive disinfectant exposure, such as vaporized or insolution hydrogen peroxide. Catheter integrity can be compromised if exposed to these substances.
• The risk associated with Imager II Angiographic Catheters outside the intended use is not known. 
• Precautions to prevent or reduce clotting should be taken when any catheter is used in the peripheral vascular system. The catheter should always be filled with either heparinized saline solution or contrast medium. Use of systemic heparinization should be considered.

PRECAUTIONS 

If any leak is detected in the device during flush or contrast media injection, exchange the catheter.

ADVERSE EVENTS

Potential adverse events which may be associated with the use of angiographic catheters when used as indicated include but are not limited to:

• Allergic reaction (contrast, device or other)
• Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA)
• Death
• Embolism (air, plaque, thrombus, device or other)
• Hematoma
• Hemorrhage
• Infection/Sepsis
• Ischemia
• Need for additional intervention or surgery
• Thrombosis/Thrombus
• Vasospasm
• Vessel Occlusion
• Vessel Trauma (arteriovenous fistula, dissection, perforation, pseudoaneurysm, rupture, or injury) 

90960881 AD.2