ProVia

Indications, Safety, and Warnings

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 guide wires are steerable guide wires 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 guide wires are not intended for use in cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.

Contraindications

None known for steerable exchange guide wires.

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 guide wire carefully for bends, kinks, coil separations, or other damage. Do not use a guide wire that has been damaged. Damage may prevent a guide wire from performing with accurate torque response and control, and may cause vessel damage.
• Always maintain visualization of the wire under fluoroscopy, ensur¬¬ing 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 and state laws and regulations.

Precautions

• Store in a cool, dark, dry place.
• Do not use open or damaged packages.
• Do not use damaged guide wires.
• Do not expose to organic solvents.
• Use prior to the expiration date.
• Steerable guide wires are delicate instruments. Exercise care while handling guide wires 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 guide wire in a metal cannula, needle, or other sharp edged instruments.
• Potential adverse events which 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: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only. See package inserts for full product information.

Please contact your local Medtronic sales representative for more information.

Test data on file at Medtronic, Inc. Bench test results may not be indicative of clinical performance.

Note: All guide wires are 0.014-in. wires and 180-cm wires are DOC compatible.