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PTFE Coated Guide Wires
INFORMATION FOR USE
For use with Balloon Dilation Catheters
Read this document in its entirety prior to use.
Description
The Medtronic PTFE coated guide wire is constructed of stainless steel with a PTFE
coating on its exterior surface. The guide wire has a fixed core, and a 3 cm flexible
distal tip.
Note:
Distal tip of “J” Guide Wire will return to proper shape after removal from
holder.
Indications for Use
For percutaneous entry of a Medtronic guiding catheter into a vessel using standard
percutaneous methods.
Contraindications
None known.
Warnings
This device is single use. Do not reuse, reprocess or resterilize. Cleaning,
disinfection and resterilization may compromise essential material and design
characteristics that may lead to device failure. Reuse of this device creates a
potential risk of patient or user infections due to contamination. This
contamination of the device may lead to injury, illness or death of the patient.
Do not use if opened or damaged.
Precautions
Inspect all guide wires for coil separation, bends and kinks, prior to use.
Guide wires, by the nature of their construction, will collect blood and other
foreign material in their lumen. Neither autoclaving nor ultrasonic cleaning will
completely remove this material, therefore, we recommend one time use.
After use, this product may be a potential biohazard. Handle and dispose of all
such devices in accordance with accepted medical practice and applicable local,
state and federal laws and regulations.
As with most percutaneous interventions, other potential adverse events include:
Vessel Dissection or Perforation, Myocardial Infarction, Pericardial Effusion and
Tamponade, Guidewire fracture and embolization, Vessel Occlusion, Thrombus,
Arrhythmias, Local or systemic infection, Stroke
Instructions for Use
The following procedure is recommended for the percutaneous introduction of the
Medtronic PTFE coated guide wire.
1. Percutaneously introduce a Medtronic insertion
instrument or appropriate substitute Medtronic catheter
introducer into the vasculature over a standard .035”
(.889mm) guide wire.
2. Remove the lead dilator, sizing dilator, and .035”
(.889mm) wire simultaneously. Take the previously
prepared guiding catheter with the preloaded .063”
(1.60mm) PTFE coated guide wire and insert into the
sheath. When inserted into the sheath the .063”
(1.60mm) guide wire should be extended
approximately 2 cm out the end of the guiding catheter.
3. Advance the Medtronic femoral guiding catheter and
the guide wire through the introducer sheath. Using
fluoroscopic control, slowly advance to the aortic arch
and then remove the .063” (1.60mm) guide wire.
4. “J” guide wires are shipped with a “J” straightener to aid in the insertion of the
guide into the insertion instrument or catheter lumen. Advance the straightener
until 2-3 mm of the tip is extended from it and insert guide into hub. Remove
straightener proximally and discard. The guide wire is now in position for
introduction of a Medtronic guiding catheter into the vasculature via normal
percutaneous methods.
Summary of Contents for PTFE
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