LEVEEN COACCESS ELECTRODE SYSTEM
Received May 7, 2009 · Event occurred Apr 9, 2009
Report 3005099803-2009-02295 · MDR key 1377956
Device
Manufacturer
Boston Scientific CorporationModel number
M001262220Catalog number
26-222
Lot number
12137577
Product problems
- Peeled/Delaminated
Patient
UNK
- Burn(s)
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORP IN 2009, THAT A LEVEEN COACCESS ELECTRODE SYSTEM WAS USED DURING A PROCEDURE PERFORMED ONE DAY PRIOR. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PT DEVELOPED A BURN AT THE INTRODUCER INSERTION POINT. THE SITE INDICATED THAT THE INSULATION WAS PEELING OFF. FURTHERMORE, THE ALOKA METAL GUIDE ATTACHMENT WAS USED WITH THIS DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LEVEEN COACCESS ELECTRODE SYSTEM. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. ADDITIONAL INFO PROVIDED BY THE SITE REGARDING THIS EVENT CATEGORIZED THE BURN AS "SLIGHT" IN DEGREE AND TREATED THE REGION WITH ICE.
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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.