Indications, Safety, and Warnings

Cardioblate MAPS Mapping, Ablation, Pacing and Sensing Device

Indications for Use

The Cardioblate MAPS Mapping, Ablation, Pacing and Sensing Device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

Contraindications

The Cardioblate MAPS Mapping, Ablation, Pacing and Sensing Device should not be used for:

• Patients that have active endocarditis at the time of surgery

Potential Complications

Possible complications related to the ablation of cardiac tissue in combination with open heart surgery are:

• Tissue perforation
• Extension of Extracorporeal bypass
• Perioperative heart rhythm disturbances (atrial and/or ventricular)
• Postoperative embolic complications
• Pericardial effusion or tamponade
• Injury to the great vessels
• Valve leaflet damage
• Conductions disturbances (SA/AV node)
• Acute ischemic myocardial event

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete listing of all indications, contraindications, precautions and warnings, please refer to the Instructions for Use which accompany each product.