49313

Cardioblate™ irrigated surgical ablation pen

Indications, Safety, and WarningsIndications for useThe Cardioblate™ surgical ablation pen is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.ContraindicationsThe Cardioblate™ surgical ablation pen 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 (United States) 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.UC202410605EN

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