Warning; Device Description; User Information; Contents - Boston Scientific Comet Mode D'emploi

Comet
™
Pressure Guidewire
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

WARNING

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 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 cross-infection, 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.
After use, dispose of product and packaging in accordance with hospital,
administrative and/or local government policy.

DEVICE DESCRIPTION

The Comet Pressure Guidewire is a single use, hydrophilic-coated, steerable
wire with a custom optical cable. A pressure sensor is mounted approximately
3 cm from the distal end of the radiopaque and shapeable straight tip. For product
specifications, including wire diameter, length, and radiopaque tip length, please
refer to the product label.
Brachial and femoral markers are located on the proximal segment of the pressure
guidewire to aid in estimating the pressure guidewire's position relative to the
distal guide catheter tip. The proximal markers are compatible with brachial and
femoral guide catheters that are at least 90 cm or 100 cm long, respectively.
Flexible Length - 33 cm
Hydrophilic Coating
Pressure
Radiopaque Tip - 3 cm
Sensor
Figure 1. Comet Pressure Guidewire
Working Length - 185 cm
PTFE Coating
0.014 in
Brachial
(≤0.36 mm) Mark
(90 cm)
Pressure Guidewire

USER INFORMATION

Intended users of the pressure guidewire are primarily interventional cardiologists
trained in performing endovascular procedures in the sterile field. Catheterization
lab technicians and/or nurses trained in assisting endovascular procedures are
also intended users for preparation and system utilization.

Contents

Quantity Material
(1) Pressure Guidewire
(1) Torque Device
(1) Optical Cable

INTENDED USE

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

INDICATIONS FOR USE

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

CONTRAINDICATIONS

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

WARNINGS

• The Comet Pressure Guidewire should be used only by physicians trained in
angiography and percutaneous interventions including transluminal coronary
angioplasty (PTCA). 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.
Femoral
Mark
(100 cm) Handle
Torque Device
3
Cable Length - 2 m
Connector
Optical Cable
Black (K) ∆E ≤5.0