LEVEEN SUPERSLIM NEEDLE ELECTRODE

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN SUPERSLIM NEEDLE ELECTRODE WAS USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED IN 2007 (PATIENT AGE, GENDER AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE RF GENERATOR SHUTDOWN. THE SITE CHECKED THE GENERATOR WITH A PHANTOM AND NO ANOMALY WAS NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER LEVEEN SUPERSLIM NEEDLE ELECTRODE AND THE SAME RF GENERATOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

Additional Manufacturer Narrative

NO CONSEQUENCES OR IMPACT TO PATIENT. OTHER (UNKNOWN). A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO VISUAL DEFECTS. HEAVY RESIDUE WAS PRESENT ON THE TINES, WHICH INDICATES THAT THE DEVICE WAS USED. WHILE COMPLETING A FUNCTIONAL CHECK OF THE ARRAY'S ABILITY TO EXTEND AND RETRACT, RESISTANCE WAS ENCOUNTERED. A VISUAL EVALUATION FOUND THAT THE ARRAY WAS IN THE PROPER UMBRELLA SHAPE, BUT THE UMBRELLA WAS SLIGHTLY TILTED. NO CONNECTIVITY ISSUE WAS FOUND WITH THE DEVICE. THE TINES OF THE ARRAY CONDUCTED CURRENT APPROPRIATELY. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE DEVICE LED TO A POWER FAILURE IN THE RF GENERATOR. THE MOST PROBABLE ROOT CAUSE IS UNKNOWN. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.