Cardioblate

Indications, Safety, and Warnings

Cardioblate MAPS (Mapping, Ablation, Pacing and Sensing) Device

Indications for Use

The Cardioblate^® MAPS Surgical Mapping, Ablation, Pacing, and Sensing Device is a sterile, single use electrosurgery device intended to ablate cardiac tissue using radiofrequency energy when connected to the Cardioblate^® 68000 Generator or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to an external temporary cardiac pacemaker.

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

Adverse Effects

Possible adverse effects related to the use of this instrument in combination with cardiac 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, conduction disturbances (SA/AV node), acute ischemic myocardial event, thrombus formation, nerve damage, unintentional burns, pericarditis, pleural effusion, esophageal perforation, death, coronary sinus perforation, coronary artery spasm, atrial lead dislodgement, hypotension, cerebrovascular accident, transient ischemic attack, blood loss.

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.