BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER® TORQVUE® 45° DELIVERY SYSTEM

    MDR report key: 2120431 · Received June 10, 2011

    Report

    Report Number
    2135147-2011-00066
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 10, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    DQY
    PMA / PMN Number
    K072313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 8F (B)(4) SHEATH WAS RETURNED TO AGA MEDICAL AND DECONTAMINATED. THE SHEATH WAS EXAMINED AND THE TIP WAS OBSERVED TO BE PARTIALLY INVERTED. A TEST 12MM ASO WAS LOADED INTO A TEST LOADER WITH A TEST DELIVERY CABLE, HANDED-OFF, ADVANCED, DEPLOYED, AND RECAPTURED USING THE RETURNED 8F (B)(4) SHEATH. THE RECAPTURE WAS SUCCESSFUL; HOWEVER, THE SHEATH TIP PARTIALLY INVERTED ONCE AGAIN. DURING MANUFACTURING, THIS DELIVERY SYSTEM LOT UNDERWENT A SERIES OF INSPECTIONS TO VERIFY THE INTEGRITY OF THE SHEATH. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DELIVERY SYSTEM LOT SUCCESSFULLY COMPLETED THESE INSPECTIONS. OUR INVESTIGATION CONFIRMED THE APPEARANCE DESCRIBED IN THE FIELD. WE HAVE FORWARDED THIS INFORMATION ONTO OUR MANUFACTURING ENGINEERING AND PROCESS DEVELOPMENT TEAMS FOR ADDITIONAL REVIEW. AGA HAS ALSO RECENTLY REVIEWED THE SHEATH TIP MANUFACTURING PROCESS AND IMPLEMENTED ADDITIONAL INSPECTIONS AND AUTOMATED PROCEDURES TO ENSURE HIGHER QUALITY SHEATH TIPS.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, THE 8F AMPLATZER TORQUE 45 DEGREE DELIVERY SYSTEM ((B)(4)) WAS SELECTED TO ADVANCE THE 12MM AMPLATZER SEPTAL OCCLUDER (ASO) FOR CLOSURE OF A SECUNDUM-TYPE ATRIAL SEPTAL DEFECT. THE (B)(4) FAILED TO RETRACT THE EXPANDED ASO DURING REPOSITIONING. THE (B)(4) WAS EXCHANGED WITH A 9F AMPLATZER EXCHANGE SYSTEM AND THE ASO WAS SUCCESSFULLY RETRACTED AND IMPLANTED. UPON REMOVAL OF THE (B)(4) SHEATH, THE TIP WAS FOUND TO BE DEFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER® TORQVUE® 45° DELIVERY SYSTEM DELIVERY SYSTEM DQY AGA MEDICAL CORPORATION 9-ITV08F45/80 1101061963

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention