DFU 50536044

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.

 INTENDED USE/INDICATIONS FOR USE

INTENDED USE

The Comet II Pressure Guidewire measures blood pressure gradient across coronary and peripheral lesions during endovascular procedures. The Comet II Pressure Guidewire may also be used as a coronary or peripheral guidewire for interventional treatments.

INDICATIONS FOR USE

The Comet II Pressure Guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels.

CONTRAINDICATIONS

The Comet II Pressure Guidewire is contraindicated for use in the cerebral vasculature.

WARNINGS

• The Comet II Pressure Guidewire should be used only by physicians experienced in angiography and percutaneous interventions including transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA). Vessel trauma (dissection, perforation, rupture or injury) may result from the improper use of this device.
• Resulting pressure guidewire fractures/separations might require additional percutaneous intervention or surgery.
• Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated.
• Severe reaction may occur in response to contrast agents that cannot be adequately premedicated.

PRECAUTIONS

1. Remove the pressure guidewire carefully from the carrier tube to reduce the possibility of damage to the distal tip. Refer to the Diagnostic Procedure section.
2. The pressure guidewire should be wiped clean only with heparinized saline prior to use to prevent thrombus accumulation.
3. Maintain diligent control of the distal tip at all times during an intervention to avoid vessel dissections and perforations. The pressure guidewire should be manipulated in the body only under fluoroscopy. The pressure guidewire should never be advanced, removed, and/or torqued against resistance without first determining the reason for resistance. If ability to torque the pressure guidewire is diminished during procedure and the source of torque loss is not known, remove the guidewire without further torquing.
4. Exercise care in handling the pressure guidewire during a procedure to reduce the possibility of accidental breakage, bending, kinking, tip or wire separation or other damage to the pressure guidewire.
   •  Do not use a pressure guidewire that has been damaged as it may decrease performance characteristics and/or lead to vessel damage.
   • Do not attempt to straighten a pressure guidewire that has been kinked or bent.
   • Do not leave the pressure guidewire in a prolapsed condition, as damage to the pressure guidewire may occur.
   • Wire damage may occur when the pressure guidewire is manipulated in a sharp bend, such as that caused by incomplete coaxial alignment of the delivery catheter and ostium, creating a sharp bend of the pressure guidewire between the delivery catheter and the vessel wall. Sharp bends are more likely to occur when using a less supportive delivery catheter, such as a diagnostic catheter.
5. When crossing a stent, exercise care to avoid entanglement between the pressure guidewire and the stent.
6. Avoid abrasion of the pressure guidewire coating.
   • To avoid damage to the hydrophilic coating, do not withdraw or manipulate the pressure guidewire in a metal cannula or sharp object.
   • Due to the variations of certain catheter tip inner diameters, abrasion of the hydrophilic coating may occur during manipulation. If any resistance is felt during introduction of the catheter, use a different catheter.
   • Excessive tightening of the torque device onto the pressure guidewire may result in abrasion of the coating on the pressure guidewire.
7. Exercise care in handling the optical cable during a procedure to reduce the possibility of accidental breakage, bending, kinking, or other damage.
8. Use only the optical cable provided to connect the pressure guidewire to FFR Link. Use of a different optical cable will produce inaccurate pressure readings.
9. Keep the proximal end of the pressure guidewire clean to ensure proper connection to the optical cable.
10. The accuracy of the diagnostic information is affected by, but not limited to:
    • Failure to achieve maximum coronary and myocardial hyperemia if using FFR (Fractional Flow Reserve) modality.
    • Interventional devices, such as balloon catheters, which are positioned so as to affect the blood flow or guidewires that stretch the vessel.
    • Pressure wire positioning relative to the lesion.
    • Microvascular resistance. 
11. Carefully check and match therapeutic device compatibility to the pressure guidewire prior to use. Refer to instructions supplied with any interventional devices to be used in conjunction with pressure guidewire for their intended uses, contraindications and potential complications.
12. Do not use the pressure guidewire in conjunction with atherectomy catheters. It may damage the pressure guidewire.

POTENTIAL ADVERSE EVENTS

ADVERSE EVENTS

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

• Abrupt closure
• Angina or unstable angina
• Allergic reaction
• Arrhythmias
• Cardiac tamponade/pericardial effusion
• Contrast induced renal insufficiency or renal failure
• Death
• Embolism
• Exposure to biohazardous material
• Infection
• Myocardial infarction or ischemia
• Radiation injury
• Restenosis (reocclusion)
• Spasm
• Stroke/cerebral vascular accident (CVA)/transient ischemic attack (TIA)
• Vascular thrombus
• Vessel trauma (dissection, perforation, rupture or injury)

Some of the potential adverse events may require additional intervention including surgery.

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