LEVEEN COACCESS ELECTODE SYSTEM

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO ONE OF SIX DEVICES USED DURING THE SAME PROCEDURE. MFR REPORT # 3005099803-2009-04853, 04854. 04855, 04856, AND 04850 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A RF 3000 RADIOFREQUENCY GENERATOR, A LEVEEN COACCESS ELECTRODE SYSTEM AND FOUR RETURN GROUNDING PADS WERE USED DURING A RADIOFREQUENCY ABLATION (RFA) PROCEDURE OF THE RIGHT KIDNEY. ACCORDING TO THE COMPLAINANT, AFTER THE ABLATION, BURNS WERE OBSERVED AROUND THE ADHESIVE SECTIONS OF THE GROUNDING PADS. THREE OF THE FOUR BURNS WERE FIRST DEGREE, WHILE THE FOURTH WAS CONSIDERED SECOND DEGREE DUE TO A BLISTER DEVELOPING AROUND THE AREA. THE BURNS WERE APPROX. 5X3CM IN SIZE AND WERE IMMEDIATELY TREATED WITH FLAMAZINE CREAM. THE SITE INDICATED THAT APPROPRIATE TREATMENT ALGORITHMS WERE FOLLOWED ON EACH OF THE TWO ABLATION ATTEMPTS. HOWEVER, ROLL-OFF WAS ONLY ACHIEVED ON THE SECOND ATTEMPT. THE ABLATION WAS COMPLETED AND THE PROCEDURE TIME TOTALED APPROX ONE HOUR. THE PT'S CONDITION WAS REPORTED TO BE STABLE.

Additional Manufacturer Narrative

THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFO IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.