ULTRACINCH LP, 10 CELL, UC-LP-10

Description of Event or Problem

SAME CASE AS MFR REPORT #300387001-2012-00003. IT WAS REPORTED DURING AN ABLATION PROCEDURE USING AN EPICOR ULTRACINCH LP THE PT EXPERIENCED A TEAR IN THE RIGHT ATRIAL APPENDAGE. THE PHYSICIAN NOTED AN ERROR MESSAGE DURING AN ABLATION PROCEDURE THAT READ "DAMAGED DISPOSABLE DETECTED". THE CABLES AND CONNECTIONS WERE INSPECTED, REVEALING NO CORROSION OR DAMAGE. THE CABLES WERE EXCHANGED AND CONNECTED AND THE SALINE FLOW WAS CHECKED, REVEALING NO AIR BUBBLES. A SECOND ERROR MESSAGE TRIGGERED, READING "POWER DELIVERY OUT OF RANGE". THE SALINE BAG WAS THEN COMPRESSED TO VERIFY FLOW AND THE SYSTEM WAS INSPECTED FOR AIR BUBBLES, REVEALING NONE. THE PHYSICIAN ATTEMPTED TO INITIATE THERAPY AGAIN BUT THE ERROR "POWER DELIVERY OUT OF RANGE" CONTINUED, ONLY ALLOWING THE UNIT TO RUN FOR 3 SECONDS AT A TIME. A SECOND DEVICE WAS USED AND THE SAME ERROR MESSAGE WAS DISPLAYED. AFTER THE USE OF BOTH DEVICES, A TEAR IN THE RIGHT ATRIAL APPENDAGE WAS NOTED. THE PHYSICIAN INDICATED THE RIGHT ATRIAL APPENDAGE WAS TORN DUE TO THE TRAUMA OF PASSING THE SIZING SYSTEM AROUND THE ATRIUM NUMEROUS TIMES. THE CASE WAS SUCCESSFULLY COMPLETED WITH NO ALARMS USING A (B)(4). THE PT WAS IN STABLE CONDITION AND AT THE TIME OF THIS REPORT REMAINED IN THE POST-OPERATIVE WARD WITH NO DELAY IN DISCHARGE DUE TO THIS EVENT.

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THE REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.