LEVEEN COACCESS ELECTRODE SYSTEM
Received Feb 26, 2009 · Event occurred Jan 30, 2009
Report 3005099803-2009-00789 · MDR key 1355930
Device
Product problems
- Mislabeled
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES ARE UNK. THE DEVICE HAS BEEN RECEIVED BY THIS MANUFACTURER, HOWEVER, THE INVESTIGATION HAS NOT YET BEEN PERFORMED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2009 THAT A LEVEEN COACCESS ELECTRODE SYSTEM WAS USED DURING A RADIO FREQUENCY ABLATION PROCEDURE. ACCORDING TO THE COMPLAINANT, FOLLOWING DEPLOYMENT OF THE TINES, THE PHYSICIAN FELT THE DIAMETER OF THE DEVICE WAS BIGGER THAN ITS SPECIFICATION OF 3.5CM. THE DEVICE WAS REMOVED FROM THE PT AND MEASURED. THE DIAMETER WAS DETERMINED TO MEASURE 4.0CM. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.