BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER® TORQVUE® 45° DELIVERY SYSTEM

    MDR report key: 1893944 · Received November 9, 2010

    Report

    Report Number
    2135147-2010-00159
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 8, 2010
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    DQY
    PMA / PMN Number
    K072313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS COULD NOT BE PERFORMED SINCE THE AMPLATZER TORQVUE 45 DEGREE DELIVERY SYSTEM WAS NOT RETURNED. DURING MANUFACTURING, THIS DELIVERY SYSTEM LOT UNDERWENT A SERIES OF INSPECTIONS AND TESTS TO CONFIRM PROPER FUNCTION. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DELIVERY SYSTEM LOT SUCCESSFULLY COMPLETED THESE TESTS. THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. SHOULD THE PRODUCTS BECOME AVAILABLE AT A LATER DATE, WE WILL REOPEN THE FILE AND SUBMIT A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, A 32MM AMPLATZER SEPTAL OCCLUDER'S (ASO) RIGHT ATRIAL DISC DEFORMED INTO A COBRA SHAPE UPON DEPLOYMENT. THIS WAS DOCUMENTED ON AN ANGIOGRAM SHOWING THE DEFORMED DEVICE DEFORMED WHILE IT REMAINED CONNECTED TO THE DELIVERY CABLE. FOR REASONS THAT COULD NOT BE DELINEATED, THE PHYSICIAN ENCOUNTERED DIFFICULTY RETRACTING THE ASO INTO THE SHEATH SO THE ASO WAS RELEASED FROM THE DELIVERY CABLE OF THE 12F AMPLATZER TORQVUE DELIVERY SYSTEM (DTV45). THE ASO WAS SURGICALLY REMOVED. PLEASE REFERENCE MDR 2135147-2010-00156 FOR THE ASSOCIATED ASO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER® TORQVUE® 45° DELIVERY SYSTEM DELIVERY SYSTEM DQY AGA MEDICAL CORPORATION 9-ITV12F45/80 1007064685

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR