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 PREPARATION, SEVERE RESISTANCE AND UNUSUAL SOUNDS WERE EXPERIENCED WHILE ATTEMPTING TO TEST THE ABILITY OF THE ARRAY TO EXTEND AND RETRACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER LEVEEN SUPERSLIM NEEDLE ELECTRODE, 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. NOISE; RESISTANCE, PHYSICAL. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE CANNULA NEEDLE WAS BENT SLIGHTLY. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT RESISTANCE AND AN UNUSUAL NOISE WERE ENCOUNTERED. THE MOST PROBABLE ROOT CAUSE IS HANDLING DAMAGE.