COOK Medical Roadrunner Instructions For Use Manual page 3

ROADRUNNER
CAUTION: U.S. federal law restricts this device to sale by or on the order of
a physician (or properly licensed practitioner).
DEVICE DESCRIPTION
The Roadrunner Extra Support Wire Guide features a nitinol shaft and a short,
angled platinum coil tip.
INTENDED USE
The Roadrunner Extra Support Wire Guide is intended for use in facilitating
delivery of percutaneous catheters into the cardiovascular system.
CONTRAINDICATIONS
None known
WARNINGS
•
The wire guide should be advanced only when visualizing its tip
fluoroscopically. Do not torque wire guide without evidence of
corresponding movement of distal tip.
•
Refer to labeling of percutaneous cardiovascular access catheter for
contraindications and potential complications associated with use.
•
Carefully read all instructions prior to use. Failure to observe all
warnings and precautions may result in complications.
PRECAUTIONS
•
This product is intended for use by physicians trained and experienced
in cardiovascular system access procedures. Standard techniques for
placement of vascular access sheaths, angiographic catheters, and wire
guides should be employed.
•
Withdrawal or manipulation of distal spring coil portion of wire guide
through needle tip may result in breakage.
•
This wire guide is a delicate instrument and should be handled carefully;
forceful angulation should be avoided.
INSTRUCTIONS FOR USE
1. Attach pin vise to wire guide.
2. Under fluoroscopy and while maintaining position of cardiovascular
access catheter, advance wire guide to targeted site.
WARNING: Observe all wire guide movement in vessels under
fluoroscopy. Do not torque wire guide without evidence of
corresponding movement of distal tip. Further torquing against
resistance may cause vessel trauma or wire guide damage, which may
lead to device fracture.
WARNING: Wire guide should be advanced only when visualizing wire
guide tip fluoroscopically. If resistance is noted tactilely or visually
under fluoroscopy, determine the cause and take action necessary
to relieve resistance. Advancement and withdrawal of the wire guide
should be performed slowly and carefully.
3. Upon reaching desired location, advance distal tip of wire guide distal to
lesion, placing a more supportive section of wire guide at targeted site.
4. Confirm location of wire guide in two planes to assure placement of distal
tip in desired vessel and not within a side branching vessel.
5. With wire guide secured in place, advance cardiovascular access catheter
to target site.
Wire Guide Exchange
1. Remove pin vise from wire guide.
2. Open hemostatic valve and flush line.
WARNING: Always maintain a continuous flush while exchanging wire
guides to prevent air entry into the system.
3. Withdraw wire guide under fluoroscopy slowly and gently to prevent
trauma. NOTE: After removing wire guide from catheter, wipe with sterile
gauze pad moistened with heparinized saline solution or sterile water and
place back into holder.
4. Close hemostatic valve, flush line, and prepare a new wire guide.
WARNING: Prior to re-inserting exchanged wire guide, verify that
distal tip of cardiovascular device is free within vessel. If tip is
against vessel wall, vessel trauma may result upon
re-introduction of wire guide.
HOW SUPPLIED
Supplied sterilized by ethylene oxide gas in peel-open packages. Intended
for one-time use. Sterile if package is unopened or undamaged. Do not use
the product if there is doubt as to whether the product is sterile. Store in a
dark, dry, cool place. Avoid extended exposure to light. Upon removal from
package, inspect the product to ensure no damage has occurred.
EXTRA SUPPORT WIRE GUIDE
®
3
ENGLISH