GWR419678

Attain Stability™ with Attain Hybrid™ guidewires shown vertically

Indications, Safety, and WarningsIndicationsThe Attain Hybrid™ guidewire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.ContraindicationsThe guidewire is not intended for use in the cerebral vasculature.Warnings and precautions

This device is intended only to be used once for a single patient. Do not reuse, reprocess, or resterilize this device for purpose of reuse. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device or create a risk of contamination of the device that could result in patient injury, illness, or death.

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 is damaged. Damage may prevent a guidewire from performing with accurate torque response and control, and may cause vessel damage.

Upon guidewire introduction, ensure that the lead tip is free to move within the blood vessel and is not pointed toward the vessel wall. Improper position could result in vessel damage when the guidewire exits the lead.

Always maintain visualization of the guidewire under fluoroscopy, ensuring that the tip is moving freely when torque is applied. If the tip is not rotating freely, never turn the guidewire 360° in the same direction.

Do not push, pull, or rotate the guidewire against resistance. If resistance is met, discontinue movement of the guidewire, determine the reason for resistance, and take appropriate action before continuing. Do not use excessive force or surgical instruments when inserting the guidewire into the lead. Avoid overbending or kinking the guidewire. Do not expose the guidewire to organic solvents. Exercise care while handling guidewires to help prevent the possibility of coil separation, uncoiling, kinking, or breakage.

Potential ComplicationsPotential complications related to the use of the guidewire include, but are not limited to, the following: air embolism, cardiac perforation, coronary sinus dissection, coronary sinus perforation, heart block.See the device instructions for use for detailed information regarding the procedural instructions, indications, contraindications, warnings, precautions, and potential complications/adverse events. Because the guidewire is a functional extension of the lead, review the lead documentation for all appropriate warnings, complications, precautions, and instructions. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at medtronic.com.Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician.

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