BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER TORQVUE FX DELIVERY SYSTEM

    MDR report key: 2913020 · Received January 14, 2013

    Report

    Report Number
    2135147-2013-00003
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    DQY
    PMA / PMN Number
    K121611
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TVFX TETHER CABLE WAS RETURNED TO SJM WITH THE MALE END SCREW MISSING AND FRACTURED FROM THE REMAINDER OF THE RETURNED CABLE. THE NITINOL CORE WIRE WAS EXAMINED AND THE FRACTURE SURFACE WAS FOUND SMOOTH WITH EVIDENCE OF TORSIONAL FAILURE. ALL COMPONENTS WERE RETURNED WITHIN SPECIFICATION AND THE FAILURE WAS DEEMED TO BE NOT RELATED TO MANUFACTURING. DURING MANUFACTURING, THIS DELIVERY SYSTEM LOT UNDERWENT A SERIES OF INSPECTIONS AND TESTS TO CONFIRM PROPER FUNCTION, INCLUDING SIMULATED USE BY ATTACHING AND DETACHING A THREAD GAGE TO THE DELIVERY CABLE END SCREW. REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DELIVERY SYSTEM SUCCESSFULLY PASSED THESE INSPECTIONS. THE AMPLATZER TORQVUE FX DELIVERY SYSTEM WAS THE SUBJECT OF A VOLUNTARY RECALL INITIATED BY SJM ON JANUARY 18, 2013. THE RECALL WAS NOT DUE TO ANY ONE PARTICULAR EVENT.

    Description of Event or Problem · 1

    A 10F AMPLATZER TORQVUE FX (TVFX) WAS USED TO DELIVER A 24MM AND 28MM AMPLATZER SEPTAL OCCLUDER (ASO), HOWEVER, BOTH WERE FOUND TO BE TOO SMALL AND KEPT PULLING THROUGH THE DEFECT DUE TO THE OVAL SHAPE OF THE DEFECT DESPITE THREE ATTEMPTS WITH EACH DEVICE. A 32MM ASO WAS ATTEMPTED THREE TIMES. ON THE THIRD ATTEMPT, THE 32MM ASO WAS POSITIONED IN THE RIGHT UPPER PULMONARY VEIN THEN PULLED DOWN INTO THE DEFECT SEATING ITSELF WITH NO RESIDUAL SHUNT. THE PHYSICIAN ADVANCED THE DELIVERY CATHETER UP TO THE 32MM ASO AND ATTEMPTED TO PIN IT TO RELEASE THE ASO BUT WAS NOT AWARE ABOUT TURNING THE CORE WIRE CLOCKWISE TO RELEASE THE TENSION. AS THE ASO WAS BEING DETACHED FROM THE CORE WIRE, THE TVFX'S END SCREW BROKE LEAVING A 3MM PIECE IN THE ASO PIN WHICH REMAINS IN THE PATIENT; HE FELT IT WOULD BE TOO RISKY TO REMOVE THE ASO WITH THE FRACTURED END SCREW BECAUSE OF THE RISK OF EMBOLIZATION. PRIOR TO IMPLANT, THE PHYSICIAN EXPOSED THE CORE WIRE TO ATTACH THE DEVICE IN LINE WITH THE INSTRUCTIONS FOR USE AND INDICATED THE 32MM ASO WAS NOT CROSS-THREADED. THE PHYSICIAN TRIED TO KEEP THE TVFX AS CLEAN AS POSSIBLE, SOAKING AND WIPING THE CABLE DURING THE PROCEDURE, BUT INDICATED THERE WAS LIKELY BLOOD AND TISSUE ON IT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20168 AMPLATZER TORQVUE FX DELIVERY SYSTEM DELIVERY SYSTEM DQY AGA MEDICAL CORPORATION 9-ITVFX10F45/80 1210024814

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization