BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER DELIVERY SYSTEM

    MDR report key: 3192647 · Received June 27, 2013

    Report

    Report Number
    2135147-2013-00055
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    DQY
    PMA / PMN Number
    P020024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 7F AMPLATZER TORQVUE 180 DELIVERY SYSTEM (DTV180) WAS RECEIVED AT SJM AND WAS DECONTAMINATED; THE DILATOR WAS NOT RECEIVED. UPON VISUAL EXAMINATION, TWO KINKS ON THE LOADER WERE FOUND, ONE AT THE DISTAL END AND ONE AT THE PROXIMAL END. THE DELIVERY SHEATH WAS CUT APPROXIMATELY TWO-THIRDS DOWN FROM THE PROXIMAL END, AND IT WAS APPARENT THAT THE TIP OF THE SHEATH WAS NOT RETURNED, INDICATING A SECOND CUT IN THE SHEATH. DUE TO THE CUT IN THE SHEATH, A TEST DEVICE COULD NOT BE RETRACTED OR ADVANCED THROUGH IT. DURING MANUFACTURING, THIS DELIVERY SYSTEM LOT UNDERWENT A SERIES OF INSPECTIONS AND TESTS TO CONFIRM PROPER FUNCTION, INCLUDING ASSEMBLY OF THE DILATOR INTO SHEATH TO ENSURE SMOOTH OPERATION. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DELIVERY SYSTEM LOT SUCCESSFULLY COMPLETED THESE TESTS, PRIOR TO SHIPMENT. THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    DURING PREPARATION, A 7MM AMPLATZER DUCT OCCLUDER (ADO) WAS DEPLOYED AND RETRACTED USING A 7F AMPLATZER 180 DELIVERY SYSTEM (DTV180). WHEN THE ADO WAS PLACED IN THE PATIENT IT WAS VERY DIFFICULT TO FULLY DEPLOY AND COULD NOT BE RETRACTED INTO THE SHEATH. IT WAS NOT POSSIBLE TO GET GOOD PLACEMENT OF THE ADO OR RETRACT IT BACK INTO THE SHEATH. THE PATIENT WAS SENT TO OPEN HEART SURGERY TO HAVE THE ADO AND DTV180 SURGICALLY REMOVED. SEE MDR REPORT #2135147-2013-00052 FOR 7MM AMPLATZER DUCT OCCLUDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294173 AMPLATZER DELIVERY SYSTEM DELIVERY SYSTEM DQY AGA MEDICAL CORPORATION 9-ITV07F180/80 1212112620

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention