LEVEEN SUPERSLIM NEEDLE ELECTRODE

Additional Manufacturer Narrative

NO CONSEQUENCES OR IMPACT TO PATIENT. RESISTANCE, PHYSICAL. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO VISUAL DEFECTS. FURTHER, NO DAMAGE TO THE INSULATION WAS IDENTIFIED. ATTEMPTS TO EXTEND AND RETRACT THE ARRAY WERE MET WITH RESISTANCE, WHICH IDENTIFIED THE NEED TO APPLY EXCESSIVE FORCE TO COMPLETE THE ACTIONS. THE ARRAY WAS FOUND TO BE BENT AND NOT IN AN UMBRELLA SHAPE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE DEVICE WAS DAMAGED. THE MOST PROBABLE ROOT CAUSE IS USER ERROR, SINCE THE DEVICE SHOULD NOT BE USED ON BONE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

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 IN THE STERNUM PERFORMED IN EARLY 2007 (MALE PATIENT; AGE AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER THE NEEDLE WAS DEPLOYED AND REMOVED SEVERAL TIMES, IT BECAME DAMAGED (COULD NOT BE EXTENDED OR RETRACTED). THE PROCEDURE WAS 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.