LEVEEN NEEDLE ELECTRODE

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #3005099803-2009-05603 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR AND A LEVEEN NEEDLE ELECTRODE WAS USED DURING A LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED IN 2009. ACCORDING TO THE COMPLAINANT, AFTER PERFORMING THE FIRST ABLATION WITH THE ELECTRODE AND A METAL NEEDLE GUIDE, A BURN INJURY WAS FOUND AT THE PUNCTURE SITE. THE PROCEDURE CONTINUED WITH THE SAME ELECTRODE AND ANOTHER METAL NEEDLE GUIDE. AFTER TWO ADDITIONAL ABLATIONS WERE PERFORMED, SMALL BURNS WERE IDENTIFIED AT EACH OF THE TWO NEW LOCATIONS. THE ELECTRODE WAS AT EACH OF THE TWO NEW LOCATIONS. THE ELECTRODE WAS INSPECTED AND THE COATING WAS FOUND TO HAVE PEELED. THE PROCEDURE WAS COMPLETED WITH THE SAME RF 3000 RADIOFREQUENCY GENERATOR AND LEVEEN NEEDLE ELECTRODE. THE PATIENT IS UNDER A WAIT AND SEE APPROACH. HOWEVER, FOLLOW-UP INDICATED THAT NO ADDITIONAL COMPLICATIONS HAVE BEEN REPORTED.

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.