LEVEEN SUPERSLIM NEEDLE ELECTRODE
Received Oct 2, 2009 · Event occurred Sep 4, 2009
Report 3005099803-2009-04655 · MDR key 1510232
Device
Manufacturer
Boston Scientific CorporationModel number
M001262280Catalog number
26-228
Lot number
12683832
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
UNK
- No Patient involvement
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN SUPERSLIM NEEDLE ELECTRODE WAS USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2009 (AGE UNK; HOWEVER, OVER 18 YEARS OLD). ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE SHAPE OF THE EXTENDED TINES WAS NOT CORRECT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER LEVEEN SUPERSLIM NEEDLE ELECTRODE. 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. ATTEMPTS TO OBTAIN ADDITIONAL INFO REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
(B)(4) - (TINES NOT CORRECT). 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).