LEVEEN COACCESS ELECTRODE SYSTEM

Additional Manufacturer Narrative

NO CONSEQUENCES OR IMPACT TO PATIENT. RESISTANCE, PHYSICAL. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO VISUAL DEFECTS. FUNCTIONALLY, THE INTRODUCER CANNULA COULD BE PLACED ON THE NEEDLE AND LOCKED INTO PLACE IN THE HANDLE WITHOUT ISSUE. THE DEVICE ARRAY WAS CAPABLE OF BEING DEPLOYED AND RETRACTED, HOWEVER, THE EVALUATOR NOTED THE PRESENCE OF A GRINDY FEELING DURING THIS ACTUATION. THE EVALUATOR DETERMINED THAT THIS WOULD NOT HINDER THE MOVEMENT OF THE ARRAY IN AND OUT OF THE ELECTRODE CANNULA. A CHECK OF THE DISTAL END OF THE ELECTRODE CANNULA WAS COMPLETED UNDER 10X MAGNIFICATION. THE DEVICE WAS FOUND TO BE GROOVED ON THE INSIDE AND BURRED SLIGHTLY ON THE DISTAL EDGE. AFTER DISASSEMBLING THE DEVICE, SEVERAL DIMENSIONS WERE ANALYZED. THE OUTER DIAMETER OF THE ARRAY WELD JOINT WAS MEASURED AND FOUND TO BE 0.0535 INCHES, WHICH IS WITHIN THE MANUFACTURING SPECIFICATION OF 0.056 INCHES MAXIMUM. THE INNER DIAMETER OF THE ELECTRODE CANNULA WAS FOUND TO BE 0.057 INCHES, WHICH IS WITHIN TOLERANCE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT RESISTANCE WAS ENCOUNTERED DURING ACTUATION. THE MOST PROBABLE ROOT CAUSE IS UNKNOWN. 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 AN RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED IN 2006 (PATIENT AGE, GENDER AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING PREPARATION, WHEN THE NEEDLE WAS DEPLOYED AND RETRACTED, HARD FRICTION WAS ENCOUNTERED. 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.