IMPORTANT INFORMATION
Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings, and precautions.
INDICATIONS FOR USE
Medtronic guidewires are steerable guidewires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. Medtronic guidewires are not intended for use in cerebral vasculature. Medtronic steerable exchange guidewires are used to facilitate the substitution of one diagnostic or interventional device for another.
CONTRAINDICATIONS
None known for steerable exchange guidewires.
WARNINGS
- Do not reuse. Reuse of single-use devices creates a potential risk of patient or user infections due to contamination. This contamination may lead to injury, illness, or death of the patient.
- Do not reprocess or resterilize. Cleaning, disinfection, and resterilization may compromise essential material and design characteristics leading to device failure.
- Prior to use and, when possible during the procedure, inspect the guidewire carefully for bends, kinks, coil separations, or other damage. Do not use a guidewire that has been damaged. Damage may prevent a guidewire from performing with accurate torque response and control, and may cause vessel damage.
- Always maintain visualization of the wire under fluoroscopy, ensuring that the tip is moving freely when torque is applied. If the tip is not rotating freely, never turn the wire 360° in the same direction.
- Do not push, pull, or rotate the wire against resistance. If resistance is met, discontinue movement of the wire, determine the reason for resistance, and take appropriate action before continuing.
- After use, this product may be a potential biohazard. Handle and dispose of it in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.
PRECAUTIONS
- Store in a cool, dark, dry place.
- Do not use open or damaged packages.
- Do not use damaged guidewires.
- Do not expose to organic solvents.
- Use prior to the expiration date.
- Steerable guidewires are delicate instruments. Exercise care while handling guidewires to help prevent the possibility of coil separation, uncoiling, kinking, or breakage.
- To maintain integrity of the Hydro-Track™ coating, do not withdraw or manipulate the hydrophilically coated guidewire in a metal cannula, needle, or other sharp-edged instruments.
- Potential adverse events that may result from the use of this device include, but are not limited to: excessive bleeding, air embolism, ischemia, hematoma at the puncture site, infection, vessel spasm, vascular thrombosis, and vessel dissection and perforation.
Caution: Federal (USA) law restricts these devices to sale by or on the order of a licensed healthcare practitioner.
Please contact your local Medtronic sales representative for more information.
Note: All guidewires are 0.014 inch wires and 180 cm wires are DOC compatible.