Imager™ II Angiographic Catheter

Indications, Safety and Warnings

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 “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE

The IMAGER II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selectedsites in the vascular system, including the carotid arteries. Additionally, the 5F Selective IMAGER II AngiographicCatheters without side holes can also be used for the controlled and selective delivery of the Boston ScientificInterlock - 35 Detachable Coils into the peripheral vasculature..

CONTRAINDICATIONS

No known contraindications.

WARNINGS

  • Angiographic catheters are designed for use by physicians engaged in the practice of a specialized branch ofmedicine. Use of these devices should be restricted to those specialists trained to perform the procedure. A thoroughunderstanding of the technical principles, clinical applications, and risks associated with diagnostic angiography isnecessary before performing this procedure.
  • Accordingly, the IMAGER II Angiographic Catheters should only be used by physicians with a thoroughunderstanding of angiographic procedures.
  • Due to the various sizes and shapes, and the relative stiffness of angiographic catheters, extreme care must betaken when selecting and using the IMAGER™ II Angiographic Catheters to avoid damage to the vessel wallsthrough which this catheter passes.
  • Do not exceed the pressure ratings printed on the device labeling. Catheter integrity may be compromised ifpressure limits are exceeded.
  • The risk associated with IMAGER II Angiographic Catheters outside the intended use is not known.

PRECAUTIONS

Precautions to prevent or reduce clotting should be taken when any catheter is used in the vascular system. Thecatheter should always be filled with either heparinized saline solution or contrast medium. Use of systemicheparinization should be considered.

ADVERSE EVENTS

Potential adverse events (in alphabetical order) which may be associated with the use of angiographic cathetersinclude but are not limited to:

  • Access Site Related Trauma
  • Arteriovenous Fistula
  • Embolism
  • Hemorrhage
  • Infection
  • Ischemia
  • Neurological Deficit Including Stroke
  • Plaque Dislodgment
  • Pseudoaneurysm
  • Thrombus Formation
  • Vasospasm
  • Vessel Occlusion
  • Vessel Wall Damage/Dissection/Perforation/Rupture

 

90960881 AC.2

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