Important Risk Information
Surgical Ablation Devices: 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); and acute ischemic myocardial event.
Cardioblate Navigator Tissue Dissector: Using excessive force when articulating may damage the distal links and/or cause unintended tissue damage.
Cardioblate 68000 Generator: To avoid the risk of electrical shock and/or burns to the patient, do not touch the patient while touching the outer housing or connections on the Cardioblate generator. Do not allow the patient to come into contact with the grounded metal surfaces during RF energy delivery.
Cardioblate Navigator Tissue Dissector: Using excessive force when articulating may damage the distal links and/or cause intended (replace intended with unintended) tissue damage.
