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MAESTRO 4000™ Cardiac Ablation System

Indications, Safety and Warnings

Prescriptive Information

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions

INDICATIONS FOR USE

The MAESTRO 4000 Cardiac Ablation System is intended for use with BSC cardiac ablation catheters in cardiac ablation procedures. Note: Refer to the individual catheter Directions for Use for catheter compatibility to the MAESTRO 4000 Cardiac Ablation System.

CONTRAINDICATIONS

There are no specific contraindications for use of the MAESTRO 4000 Cardiac Ablation System. However, users should read and understand the specific indications, contraindications, warnings, and precautions included with any cardiac ablation catheter used in conjunction with the System. Note: The contraindications listed in the catheter Directions For Use also apply to the use of the MAESTRO 4000 Cardiac Ablation System.

WARNINGS

Do not attempt to install or operate the MAESTRO 4000 Cardiac Ablation System before thoroughly reading the Operator’s Manual, the MAESTRO 4000 Cardiac Ablation System Operator’s Manual, and the BSC open-irrigated catheter’s Directions for Use. All operating instructions should be read, understood, and followed carefully.

ADVERSE EVENTS

Users should read and understand the specific indications, contraindications, warnings, and precautions included with any catheter used in conjunction with the System. Potential adverse events associated with the MAESTRO 4000 Cardiac Ablation System are, but not limited to, the following: additional intervention required, arrhythmia, burns, cardiac arrest, cardiac tamponade, cerebral vascular accident (CVA), complete heart block, conduction pathway injury, congestive heart failure, death, discomfort, edema, electrical shock, embolism, esophagitis, exposure to biohazardous material, fistula, hematoma, infection, injury (not otherwise specified), laceration, myocardial infarction, myocardial trauma, necrosis, nerve injury, perforation, pericardial effusion, pericarditis, pleural effusion, prolonged procedure, renal damage/failure, respiratory distress/insufficiency, swallowing disorders, tissue damage, transient ischemic attach (TIA), vasospasm, vessel occlusion, vessel trauma.

(Rev A)

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