LEVEEN SUPERSLIM NEEDLE ELECTRODE

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2006 THAT A LEVEEN SUPERSLIM NEEDLE ELECTRODE DEVICE WAS USED DURING A RADIOFREQUENCY ABLATION (RFA) PROCEDURE ON THE PATIENT'S LIVER THE SAME DAY (PATIENT GENDER, AGE AND WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CANNULA MOVED OUT OF POSITION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER LEVEEN SUPERSLIM NEEDLE ELECTRODE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE GOOD.

Additional Manufacturer Narrative

NO CONSEQUENCES OR IMPACT TO PATIENT. OTHER (CANNULA MOVED OUT OF POSITION DURING THE PROCEDURE.) A VISUAL EXAMINATION OF THE RETURNED SAMPLE REVEALED THAT THE CANNULA WAS SLIGHTLY BENT APPROXIMATELY 3CM FROM THE DISTAL TIP. HAND PIECES WERE PHYSICALLY PRIED APART. ENERGY DIRECTORS OF THE SIDE OF THE PART DO NOT APPEAR TO BE CRUSHED ADEQUATELY. THE CANNULA WAS SLIGHTLY BENT APPROXIMATELY 3CM FROM THE DISTAL TIP. THE INSULATION IS APPROXIMATELY 1MM PAST THE DISTAL TIP OF THE CANNULA. THE ENERGY DIRECTORS IN THE DISTAL PORTION OF THE HAND PIECES APPEAR TO BE CRUSHED APPROXIMATELY 50%. SKIVE MARKS WERE PRESENT ON THE PLUNGER HANDLE. INSULATION APPEARS TO BE WITHIN THE MIDDLE OF THE "A" DIMENSION. THE SPECIFIC ROOT CAUSE OF COMPLAINT APPEARS TO BE FROM AN INADEQUATE WELD IN THE MANUFACTURING PROCESS.