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MAESTRO 4000™ Cardiac Ablation System

Indications, Safety and Warnings

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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

INTENDED USE/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. It is also important to carefully review the specific indications, contraindications, warnings, precautions and adverse events included with each catheter, prior to use of the catheter with the Maestro 4000 Cardiac Ablation System.

CONTRAINDICATIONS

There are no specific contraindications for use of the Maestro 4000 Cardiac Ablation System itself. 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. Carefully review the specific indications, contraindications, warnings, precautions, and adverse events included with each catheter, prior to use of the catheter with the Maestro 4000 Cardiac Ablation System

ADVERSE EVENTS

Users should also 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 use of 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

(cont’d)

• 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 Attack (TIA)

• Vasospasm

• Vessel Occlusion

• Vessel Trauma

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