LEVEEN COACCESS ELECTRODE SYSTEM
Received Feb 24, 2009 · Event occurred Jan 27, 2009
Report 3005099803-2009-00713 · MDR key 1336866
Device
Manufacturer
Boston Scientific CorporationModel number
M001262240Catalog number
26-224
Lot number
9738163
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN EARLY 2009 THAT A LEVEEN COACCESS ELECTRODE SYSTEM WAS USED DURING A HEPATIC RADIO FREQUENCY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE ROLL-OFF WAS TOO FAST (80W FOR 2 MINUTES AND 90W FOR 2 MINUTES). THE PROCEDURE WAS COMPLETED WITH ANOTHER LEVEEN COACCESS ELECTRODE SYSTEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
THE DEVICE HAS BEEN RECEIVED BY THIS MFR, HOWEVER, THE INVESTIGATION HAS NOT YET BEEN PERFORMED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.