LEVEEN COACCESS ELECTRODE SYSTEM
Received Aug 25, 2009 · Event occurred Jul 28, 2009
Report 3005099803-2009-04018 · MDR key 1456086
Device
Manufacturer
Boston Scientific CorporationModel number
M001262230Catalog number
26-223
Lot number
12667787
Product problems
- Peeled/Delaminated
Patient
Not reported
- Burn(s)
Narrative
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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN COACCESS ELECTRODE SYSTEM WAS USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED IN 2009. ACCORDING TO THE COMPLAINANT, AFTER THE ABLATION, A 1CM BURN WAS NOTED TO THE SKIN WHERE THE NEEDLE WAS INSERTED. THE BURN SEVERITY WAS NOT KNOWN. THE DEVICE WAS INSERTED INTO THE TARGET LESION WITH THE METAL NEEDLE GUIDE. THE PROCEDURE WAS COMPLETED WITH THE SAME LEVEEN COACCESS ELECTRODE SYSTEM. AT THE CONCLUSION OF THE PROCEDURE, IT WAS NOTED THAT THE INSULATION HAD PEELED OFF OF THE DEVICE. NO ADDITIONAL DETAILS ARE AVAILABLE REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT.