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ACUITY™ BREAK-AWAY Lead Delivery System

Indications, Safety and Warnings

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Indications for Use/Intended Use

The ACUITY™ BREAK-AWAY lead delivery systems are intended to access the coronary venous system during dualcatheter delivery and may be used alone (8F) or in dual catheter delivery (8F w/6F). The system serves as a conduit for the delivery of contrast medium and devices, including implantable coronary venous leads, introduced into the coronary venous system. The guidewire introducer is recommended for use during vascular procedures to assist with the introduction of the guidewire into the left ventricular lead delivery system. The torque device is recommended for use during vascular procedures in conjunction with interventional and/or diagnostic devices (including left ventricular lead delivery systems) to facilitate steering of the guidewire within the vascular anatomy. The ACUITY™ Universal Cutter is intended to facilitate Boston Scientific guide catheter removal after the Boston Scientific coronary venous lead is positioned.

Contraindications

None.

Warnings

Do not alter any of the system devices, except as described in product labeling. The user should not place side holes in the shaft of the guide catheter. Puncturing the shaft of the guide catheter with hospital instruments may lead to thrombogenesis or failure of shaft integrity. When this guide catheter is in the body, it should be manipulated while under high-quality fluoroscopic observations. Do not apply excessive torque, tension or force when manipulating the guide catheter or advancing devices through the catheter as damage could result. Severe reaction may occur in response to contrast agents that cannot be adequately premedicated. When this guide catheter is in the body, care should be taken to prevent air embolism by maintaining a closed hemostatic valve or plugging the lumen.

Precautions

Precautions It is recommended that a finishing wire be used for removal of guide catheter from the lead. It is recommended that the guide catheter be advanced using a guidewire technique. Do not use if package is opened or damaged. Use the device prior to the “Use By” date noted on the package. This product is non-pyrogenic. Guide catheters should be used only by physicians thoroughly trained in their intended use. Prior to the procedure, all equipment to be used for the procedure should be carefully examined to verify proper function and integrity. Remove the guide catheter carefully from the tray to reduce the possibility of damage.

Adverse Events

Vessel trauma may result from the improper use of this device. Other potential adverse reactions include but are not limited to, air embolism, hemotoma at puncture site, infection, vessel dissection/perforation/spasm, hemorrhage and vascular thrombosis.

Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse events. Rx only. (Rev. F)

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