LEVEEN SUPERSLIM NEEDLE ELECTRODE

Additional Manufacturer Narrative

NO CONSEQUENCES OR IMPACT TO PATIENT. RESISTANCE, PHYSICAL. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

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 UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING PREPARATION, RESISTANCE WAS ENCOUNTERED WHILE EXTENDING AND RETRACTING THE ARRAY PRIOR TO USE. A SECOND ATTEMPT WAS MADE TO CHECK THE DEVICE WITH SIMILAR RESULTS. 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.