Precautions; Adverse Events; How Supplied; Handling And Storage - Boston Scientific Comet Mode D'emploi

• 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 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 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.
Black (K) ∆E ≤5.0
- 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.

ADVERSE EVENTS

Potential adverse events which may result from the use of the device include but
are not limited to:
• Abrupt closure
• Allergic reaction
• Embolism
• Exposure to biohazardous material
• Infection
• Prolonged procedure
• Restenosis (reocclusion)
• Spasm
• Stroke/cerebral vascular accident (CVA)/transient ischemic attack (TIA)
• Vascular thrombus
• Vessel trauma (dissection, perforation, rupture or injury)
In addition, when used for interventional procedures:
• Angina or unstable angina
• Arrhythmias
• Cardiac tamponade/pericardial effusion
• Contrast induced renal insufficiency or renal failure
• Death
• Myocardial infarction or ischemia
Some of the above potential adverse events may require additional
surgical intervention.

HOW SUPPLIED

Do not use if package is opened or damaged.
Do not use if labeling is incomplete or illegible.
Do not use if the use by date has been exceeded.

Handling and Storage

Store in a cool, dry, dark place.

OPERATIONAL INSTRUCTIONS

The following are required for use with the Comet™ Pressure Guidewire:
• iLab™ Polaris Multi-Modality Guidance System or an ANSI/AAMI-BP22
compatible hemodynamic receiving system
• FFR Link
• Hemodynamic Cable Kit
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