LEVEEN COACCESS ELECTRODE SYSTEM

Additional Manufacturer Narrative

TREATMENT WITH OINTMENT. 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.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN COACCESS ELECTRODE SYSTEM WAS USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED IN 2009. ACCORDING TO THE COMPLAINANT, THE FIRST ABLATION WAS RUN AT 40W WITH HALF DEPLOYMENT AND THE OUTPUT POWER WAS INCREASED 10W PER MINUTE. ROLL-OFF OCCURRED AT 60W AND 3 MINUTES. THE SECOND ABLATION BEGAN FROM 60W WITH FULL DEPLOYMENT AND AGAIN OUTPUT POWER WAS INCREASED 10W EVERY MINUTE. ROLL-OFF WAS ACHIEVED AT 160W AT 11 MINUTES. AT THIS POINT, THE METAL PROBE OF THE ECHO PROBE WAS FOUND TO BE LOOSE; THEREFORE, THE INTRODUCER WAS RETRACTED 1CM PROXIMAL. THE THIRD ABLATION THEN BEGAN AT 30W WITH FULL DEPLOYMENT INCREASING OUTPUT POWER 10W PER MINUTE. AT 10 MINUTES, A CRACKLING SOUND WAS HEARD AT THE ABLATION SITE. THE PHYSICIAN INDICATED THAT A BURN WAS VISIBLE BETWEEN THE DEVICE AND ABLATION SITE. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND 1CM OF INSULATION HAD PEELED OFF AT 10-11CM FROM THE DISTAL END. IT WAS ALSO NOTED ANOTHER SMALL AREA HAD PEELED 8-9CM FROM THE DISTAL END. NO COATING FRAGMENTS PEELED OFF INTO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. HOWEVER, FOLLOWING COMPLETION OF THE PROCEDURE, A 2CM THIRD DEGREE BURN WAS NOTED AND TREATED WITH OINTMENT.