LEVEEN COACCESS ELECTRODE SYSTEM
Received Feb 19, 2009 · Event occurred Jan 20, 2009
Report 3005099803-2009-00637 · MDR key 1354012
Device
Product problems
- Difficult to Insert
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 PROCEDURE PERFORMED THE DAY BEFORE. ACCORDING TO THE COMPLAINANT, DURING INTRODUCTION OF THE INTRODUCER INTO AN ECHO PROBE, SEVERE RESISTANCE WAS EXPERIENCED. 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.
Additional Manufacturer Narrative
THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.