LEVEEN COACCESS ELECTRODE SYSTEM
Received Sep 15, 2009
Report 3005099803-2009-04334 · MDR key 1472728
Device
Product problems
- Peeled/Delaminated
Patient
Not reported
- Burn(s)
- Therapy/non-surgical treatment, additional
Narrative
Additional Manufacturer Narrative
THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION AND MANUFACTURE DATES ARE UNK. THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED, AND WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFO, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A LEVEEN COACCESS ELECTRODE SYSTEM WAS USED DURING AN RFA (RADIOFREQUENCY ABLATION) PROCEDURE ON A FEMALE PT. ACCORDING TO THE COMPLAINANT, FOLLOWING THE SUCCESSFUL COMPLETION OF THE PROCEDURE, IT WAS NOTED THE INSULATION PEELED OFF THE INTRODUCER OUTSIDE THE PT. NO INJURIES TO THE PT WERE NOTED AT THAT TIME. HOWEVER, SEVERAL DAYS POST PROCEDURE, A WATER BLISTER WAS NOTED ON THE SKIN OF THE PUNCTURE SITE. IT WAS DETERMINED TO BE A 3 CM THIRD DEGREE BURN AND WAS TREATED BY A DERMATOLOGIST. NO ADD'L INFO IS KNOWN REGARDING THE STATUS OF THE PT.