LEVEEN COACCESS ELECTRODE SYSTEM

Additional Manufacturer Narrative

NO CONSEQUENCES OR IMPACT TO PATIENT. PHYSICAL RESISTANCE. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO VISUAL DEFECTS WITH THE DEVICE. A FUNCTIONAL EVALUATION FOUND THAT THE ARRAY COULD BE DEPLOYED AND RETRACTED WITHOUT ANY GRINDY FEELING. WHILE SLOWLY DEPLOYING THE DEVICE, THE EVALUATOR IDENTIFIED A "JUMP" IN THE ACTUATION OF THE DEVICE. THE JUMP SEEMED TO OCCUR WITH 1.4 CENTIMETERS OF THROW LEFT IN THE HANDLE AND TRAVELLED TO 0.7 CENTIMETERS OF THROW REMAINING IN THE HANDLE. THE ACTUATION OF THE DEVICE COULD BE CONTROLLED AND THE ARRAY DEPLOYED TO DIFFERENT THROW LENGTHS BY PAYING PARTICULAR ATTENTION TO THE HANDLE DURING ACTUATION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT A JUMP OCCURRED DURING ACTUATION. THE ROOT CAUSE COULD NOT BE DETERMINED. 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 COACCESS ELECTRODE SYSTEM WAS USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE IN THE LIVER PERFORMED IN EARLY 2007 (PATIENT AGE, GENDER AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING PREPARATION, WHILE TESTING DEPLOYMENT AND RETRACTION OF THE DEVICE, HARD FRICTION WAS ENCOUNTERED. THE SITE INDICATED THAT WHEN THE ARRAY WAS DEPLOYED SLIGHTLY, IT THEN "JUMPED OUT AND DEPLOYED FULLY." THE PHYSICIAN BELIEVED THE ARRAY COULD NOT BE CONTROLLED AND STOPPED USING THIS DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LEVEEN COACCESS ELECTRODE SYSTEM 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. .