Starter™ Guidewire

INTENDED USE/INDICATIONS FOR USE

Starter guidewires are designed for percutaneous peripheral vessel entry using the Seldinger technique to facilitate subsequent introduction(s) of an intravascular device.

CONTRAINDICATIONS

Starter guidewires are not intended for use in the cerebrovasculature or coronary arteries.

WARNINGS

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, administrativeand/or local government policy.

Vessel trauma may result from the improper use of this device. Follow the enclosed directions carefully. When the guidewire is in the body, it should be manipulated only under flouroscopy. Do not attempt to move the wire without observing the resultant tip response. Never advance the guidewire against resistance without first determining the reason for resistance under fluoroscopy. Excessive force against resistance may result in separation of the guidewire tip, damage to the catheter, or vessel damage.

For Starter movable core guidewires, do not advance the movable core while it is positioned in a curved vessel.Advancement and excessive force may cause movable core penetration of the guidewire coil resulting in possible vessel damage.

Avoid withdrawing a guidewire through metal needles; guidewires may shear or coating may scrape off against the needle bevel.

PRECAUTIONS

Use the device prior to the “Use By” date noted on the package. Starter™ guidewires should be used only by physicians thoroughly trained in interventional procedures. Prior to use, all equipment to be used for the procedure should be carefully examined to verify proper function and integrity.

The Starter guidewires are supplied STERILE and in the unopened and undamaged package. Starter guidewires are sterilized by ethylene oxide gas. Verify that the sterility of the device has not been compromised by assuring the package integrity has been maintained.

Remove the guidewire carefully from the carrier tube to reduce the possibility of damage to the distal tip.

Exercise care in handling of the guidewire during a procedure to reduce the possibility of accidental breakage, bending, kinking, or coil separation. Do not use a guidewire that has been damaged. Do not attempt to straighten a wire that has been kinked or bent. Do not advance a kinked guidewire into a balloon catheter or guidewire to reduce the potential of wire breakage.

POTENTIAL ADVERSE EVENTS

Other potential adverse reactions which may result from the improper use of this device include, but are not limited to:

• Embolism (air, plaque, thrombus, device, or other)
• Hematoma at the puncture site
• Hemorrhage
• Infection
• Vascular thrombosis
• Vessel spasm
• Vessel trauma and perforation of the vessel

97440447 A