Distal tip offset from catheter’s central lumen provides multiple benefits:

• Perform angiography without removing and repositioning the guidewire.
• Obtain simultaneous pressure gradient measurements.
• Place multiple catheters on a single guidewire.
• Precisely control pull-back or push-up pressure tracings.

hCatheter Characteristic

The MULTI-TRACK™ angiographic catheter is a single lumen catheter with side holes at the tip and a 1cm section at the distal tip for catheter tracking. The tubing of the catheter is radiopaque for proper visualization under fluoroscopy.

How Supplied

Supplied sterilized by ethylene oxide gas. Sterile and non-pyrogenic if package is unopened or undamaged. Do not use the product if there is doubt as to whether the product is sterile. Avoid extended exposure to light. Upon removal from package, inspect the product to ensure no damage has occurred.

Warrnings

• This device is intended for single use only. Do not resterilize and/or reuse it, as this can potentially result in compromised device performance and increased risk of cross contamination.

• Do not advance the MULTI-TRACK™ angiographic independent from the guidewire.

• Do not advance the guidewire or any other component if resistance is met, without first determining the cause and taking remedial action.

• The rated burst pressure for this device is 1000 psi. Do not exceed 1000 psi.

Precautions

• The MULTI-TRACK™ angiographic catheter procedures should be conducted under fluoroscopic guidance with appropriate x-rayequipment.

• Guidewires are delicate instruments. Care should be exercised while handling to help prevent the possibility of breakage.

• Careful attention must be paid to the maintenance of tight catheter connections and aspiration before proceeding to avoid air introduction into the system.

• Under no circumstances should any portion of the catheter system be advanced against resistance. The cause of the resistance should be identified with fluoroscopy and action taken to remedy the problem.

• Proper functioning of the catheter depends on its integrity. Care should be used when handling the catheter. Damage may result from kinking, stretching, or forceful wiping of the catheter.

• Do not use excessive force on the catheter. During an angiographic procedure, excessive force is determined to be the force required to bend a standard 0.035" guidewire.

• The flow rates have been calculated as follows at 1000 psi:

Potential complications related to the introduction of the catheter into the body include, but are not limited to, the following:

1) Infection,

2) Air embolism, and

3) Hematoma formation.