LEVEEN COACCESS ELECTRODE SYSTEM

Additional Manufacturer Narrative

OTHER (ROLL-OFF NOT ACHIEVED). THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT # 3005099803-2009-00436. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN EARLY 2009 THAT A RF 3000 RADIOFREQUENCY GENERATOR AND A COACCESS ELECTRODE SYSTEM WERE USED DURING A RADIO FREQUENCY ABLATION PROCEDURE PERFORMED THREE DAYS PRIOR. ACCORDING TO THE COMPLAINANT, THE ABLATION WAS STARTED AT 40W; HOWEVER, ROLL-OFF WAS NOT ACHIEVED AFTER THIRTEEN MINS. A SECOND ABLATION WAS STARTED AT 40W FOR THIRTEEN MINS AND A THIRD ABLATION WAS STARTED AT 40W FOR 10 MINS. HOWEVER, ROLL-OFF WAS NOT ACHIEVED DURING THESE ADDITIONAL TWO ATTEMPTS. THE PROBE WAS REMOVED AND REINSERTED AT THE BEGINNING OF EACH ATTEMPT. THE PROCEDURE WAS ABORTED FOLLOWING THE THIRD ATTEMPT. NO ADDITIONAL DETAILS REGARDING PT FOLLOW-UP WERE AVAILABLE. ALTHOUGH THE PROCEDURE WAS NOT COMPLETED, THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION WAS REPORTED TO BE FINE.