LEVEEN COACCESS ELECTRODE SYSTEM
Received Oct 9, 2009 · Event occurred Sep 9, 2009
Report 3005099803-2009-04733 · MDR key 1512769
Device
Manufacturer
Boston Scientific CorporationModel number
M001262220Catalog number
26-222
Lot number
12049697
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
Not reported
- Burn(s)
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A LEVEEN COACCESS ELECTRODE SYS WAS USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED IN 2009 (MALE PT ). ACCORDING TO THE COMPLAINANT, A LEVEEN COACCESS NEEDLE WAS USED INSTEAD OF A NON-COACCESS NEEDLE. HOWEVER, THE PHYSICIAN FAILED TO SHEATH THE ELECTRODE PRIOR TO USE. DUE TO THIS, THE LENGTH OF THE ELECTRODE FROM THE TIP TO THE BASE REMAINED EXPOSED, AND BURNED THE PT ON THE ABDOMEN FROM THE LIVER THROUGH TO THE SKIN. THE BURN WAS ESTIMATED TO BE 2CM WIDE BY 1CM LONG, AND SEVERAL CENTIMETERS DEEP. IT WAS REPORTED THAT THE PHYSICIAN DID NOT TREAT THE BURN RIGHT AWAY. HOWEVER, THE BURN WOULD BE CUT OF THE TISSUE LATER IN THE PROCEDURE. IT WAS ALSO REPORTED THAT THE PHYSICIAN WILL CONTINUE FOLLOW-UP WITH THE PT TO TREAT THE BURN. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.
Additional Manufacturer Narrative
THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON 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.