LAVEEN COACESS ELECTRODE
Received Dec 1, 2009 · Event occurred Oct 29, 2009
Report 3005099803-2009-05634 · MDR key 1557424
Device
Manufacturer
Boston Scientific CorporationModel number
M001262220Catalog number
26-222
Lot number
12736596
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN COACCESS ELECTRODE WAS USED DURING A LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2009. ACCORDING TO THE COMPLAINANT, AFTER INSERTING THE ELECTRODE INTO THE HEPATIC VEIN, DIFFICULTY WAS ENCOUNTERED WHILE ATTEMPTING TO EXTEND THE NEEDLE. THE NEEDLE WAS ABLE TO BE EXTENDED A FEW MILLIMETERS TO SLIGHTLY ABLATE THE SITE. HOWEVER, THE PROCEDURE WAS CONTINUED AND COMPLETED WITH ANOTHER LAVEEN COACCESS 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.
Additional Manufacturer Narrative
EXTEND, DIFFICULT TO. 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. (B)(4).