LEVEEN COACCESS ELECTRODE SYSTEM
Received Sep 1, 2009 · Event occurred Aug 3, 2009
Report 3005099803-2009-04098 · MDR key 1497207
Device
Manufacturer
Boston Scientific CorporationModel number
M001262230Catalog number
26-223
Lot number
12667129
Product problems
- Difficult or Delayed Positioning
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
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. (B)(4).
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A LEVEEN COACCESS ELECTRODE SYSTEM WAS USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2009 (PT OVER 18 YEARS OLD). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AFTER PIERCING THE TUMOR, THE HANDLE WAS ACTUATED; HOWEVER, THE TINES FAILED TO FULLY EXTEND. THE TINES WERE RETRACTED AND THE DEVICE WAS REMOVED. THE SITE INDICATED THAT NO DEVICE DAMAGE WAS VISIBLE PRIOR TO USE AND THE TINES DEPLOYED AS INTENDED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LEVEEN COACCESS ELECTRODE SYSTEM. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.