LEVEEN SUPERSLIM NEEDLE ELECTRODE

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LEVEEN NEEDLE ELECTRODE WAS USED DURING A RF ABLATION PROCEDURE PERFORMED IN 2006 (PATIENT GENDER, AGE, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, ABLATION WAS PERFORMED FIVE TIMES ON A 3MM TUMOR UNDER THE CT. WHEN THE NEEDLE WAS SLIGHTLY PULLED BACK AFTER THE TINE WAS PUT INTO THE CANNULA, IT SOME RESISTANCE WAS FELT. WHEN THEY TRIED TO ROTATE THE NEEDLE 180 DEGREES WITH THE HANDLE FULLY PULLED BACK, IT FELT UNUSUAL. THE ABLATION WAS SUCCESSFULLY PERFORMED WHEN THE POSITION WAS SLIGHTLY SHIFTED. ALTHOUGH THE HANDLE WAS FULLY PULLED BACK AFTER THAT, THE TINE WAS DEPLOYED UNDER THE CT. THE HANDLE WAS BROKEN UP WITH NIPPERS AND CHISEL. THE SHAFT GOT BARED AND THE TINE WAS SLOWLY PULLED BACK. THEREFORE, THE TINE WAS FULLY PULLED BACK AND THE UNIT WAS SUCCESSFULLY REMOVED FROM THE BODY. NO DAMAGE AND GAP WERE NOTED AT THE INSULATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD."

Additional Manufacturer Narrative

A 3.0 LEVEEN NEEDLE ELECTRODE IN FOUR PIECES, WHICH CONSIST OF THE PLUNGER ARRAY ASSEMBLY, TWO HANDLE HALVES, AND THE CANNULA. THE CANNULA FLARE WAS PLACED INTO SLOT OF ONE OF THE HALVES OF THE HAND PIECE, PLACED SECOND HALF OVER TOP OF THE OTHER WITH THE CANNULA FLARE. SLIGHT COMPRESSION AND TENSION TO THE CANNULA WAS APPLIED. THE COMPONENT DID NOT MOVE; THE TWO HALVES HELD THE CANNULA PROPERLY. HAND PIECES WERE DISASSEMBLED AND THE FOLLOWING WAS NOTED: SLIGHT BLOOD UNDERNEATH HAND PIECE AT THE PROXIMAL END. NO DAMAGE TO THE INSULATION WAS OBSERVED. "OUTER" ENERGY DIRECTORS OF MOLDED HAND PIECES ARE NOT COMPLETELY CRUSHED, ONLY APPROXIMATELY 50% CRUSH. ""INNER"" ENERGY DIRECTORS APPEAR TO BE CRUSHED PROPERLY. DUE TO THE NATURE OF THE DAMAGE, THIS COMPLAINT CANNOT BE CONFIRMED. HOWEVER, UPON FURTHER INVESTIGATION OF THE COMPONENTS, IT APPEARS THAT THE ENERGY DIRECTORS OF THE MOLDED HANDLE HALVES HAVE NOT BEEN ADEQUATELY CRUSHED, MEANING THAT THERE IS A POSSIBILITY THAT THE ULTRASONIC WELD WAS NOT SUFFICIENT DURING MANUFACTURING.