LEVEEN SUPERSLIM NEEDLE ELECTRODE

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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT# 3005099803-2009-05080 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR AND A LEVEEN SUPERSLIM NEEDLE ELECTRODE WERE USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE IN THE LIVER PERFORMED ON (B)(6), 2009. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AN ERROR (E02) WAS DISPLAYED ON THE CONSOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURER'S DEVICE (COOLTIP RF SYSTEM, VALLEYLAB). 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.