LEVEEN SUPERSLIM NEEDLE ELECTRODE

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2007 THAT A LEVEEN SUPERSLIM NEEDLE ELECTRODE DEVICE WAS USED ON A MALE PATIENT DURING A RADIOFREQUENCY ABLATION (RFA) PROCEDURE ON A 3 CM LIVER TUMOR THE SAME DAY (PATIENT AGE AND WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, THIS WAS THE PHYSICIAN'S FIRST RFA PROCEDURE UTILIZING THE LEVEEN NEEDLE DEVICE. THE NEEDLE WAS USED IN CONJUNCTION WITH ANOTHER MANUFACTURER'S NEEDLE GUIDE. THE PHYSICIAN ENCOUNTERED DIFFICULTIES PUNCTURING THE TARGET REQUIRING FIVE PUNCTURES. TWO ABLATIONS WERE PERFORMED, HOWEVER, THE NEEDLE DID NOT BOW DURING THE ABLATIONS. FOLLOWING THE SECOND ABLATION, INSPECTION OF THE NEEDLE REVEALED A SCRATCH ON THE INSULATION. ANOTHER LEVEEN NEEDLE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

NO CONSEQUENCES OR IMPACT TO PATIENT. SHARP/JAGGED/ROUGH/ETCHED/SCRATCHED. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.