ULTRACINCH LP, DEPLOYABLE TISSUE ABLATION, 11 CELL

Additional Manufacturer Narrative

WE WERE UNABLE TO EVALUATE THE PRODUCT INVOLVED IN THIS INCIDENT SINCE NO COMPONENTS OF THE DEVICE WERE RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT DONE AS THE LOT NUMBER OF THE DEVICE IS NOT KNOWN. BASED ON THE INFORMATION PROVIDED TO ST. JUDE MEDICAL, THE CAUSE FOR THE REPORTED BRADYCARDIA AND HYPOTENSION REMAINS UNKNOWN. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: (B)(6)2010. DATE THE INITIAL REPORTER PROVIDED THE INFORMATION TO THE MANUFACTURER: (B)(6)2010.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF AF AND ISCHEMIC CORONARY DISEASE WAS TO RECEIVE CABG SURGERY AND ABLATION. WHEN THE ABLATION WAS TO BE PERFORMED, DURING MANIPULATION AND PLACEMENT OF THE ULTRACINCH 11, THE PATIENT BECAME SEVERELY HYPOTENSIVE AND BRADYCARDIC. CONSEQUENTLY, THE ABLATION COULD NOT BE PERFORMED. THE PATIENT WAS PUT ONTO THE HEART-LUNG MACHINE AND CABG WAS PERFORMED AS PLANNED. THE HOSPITAL STAY WAS NOT PROLONGED DUE TO THE EVENT.