Cardioblate MAPS Mapping, Ablation, Pacing, and Sensing Device
Indications, Safety and Warnings
Indications: 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.
Adverse Effects: 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, conduction disturbances (SA/AV node), acute ischemic myocardial event, thombus formation, nerve damage, unintentional burns, pericarditis, pleural effusion, esophageal perforation.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. For a listing of indications, contraindications, precautions, and warnings, please refer to the Instructions for Use.
For further information, please call Medtronic at (877) 526-7890 or visit www.medtronic.com.
