BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER DUCT OCCLUDER

    MDR report key: 3192609 · Received June 27, 2013

    Report

    Report Number
    2135147-2013-00052
    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
    MAE
    PMA / PMN Number
    P020024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 12/10 AMPLATZER DUCT OCCLUDER (ADO) WAS RECEIVED AT SJM AND WAS DECONTAMINATED. THE DEVICE WAS EXAMINED GROSSLY AND MICROSCOPICALLY, AND WAS CONFIRMED NOT TO CONTAIN ANY DEFECTS OR ABNORMALITIES. THE ADO WAS CONFIRMED TO MEET DIMENSIONAL SPECIFICATIONS WHEN MEASURED WITH A CALIBRATED CALIPER. THE ADO WAS SUCCESSFULLY LOADED INTO A TEST LOADER, ADVANCED, AND RETRACTED THROUGH A TEST 7F SHEATH WITHOUT ANY DEFORMATIONS OR DIFFICULTY. DURING MANUFACTURING, THIS DEVICE UNDERWENT A SERIES OF INSPECTIONS AND TESTS TO CONFIRM PROPER FUNCTION, INCLUDING A TEST SIMULATING LOADING AND DEPLOYMENT. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DEVICE SUCCESSFULLY COMPLETED THESE TESTS, PRIOR TO SHIPMENT. THE CAUSE FOR 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 2135147-2013-00055 FOR AMPLATZER 180 DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292472 AMPLATZER DUCT OCCLUDER CARDIAC OCCLUSION DEVICE MAE AGA MEDICAL CORPORATION 9-PDA-007 M08G08-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention