BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER DUCT OCCLUDER

    MDR report key: 1230163 · Received November 17, 2008

    Report

    Report Number
    2135147-2008-00107
    Event Type
    Injury
    Date Received
    November 17, 2008
    Date of Event
    October 17, 2008
    Report Date
    November 5, 2008
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MAE
    PMA / PMN Number
    P020024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AMPLATZER DUCT OCCLUDER WAS NOT RECEIVED FOR ANALYSIS. REVIEW OF THE MANUFACTURING RECORDS CONFIRMED THAT CERTIFIED OPERATORS FOUND THIS DELIVERY SYSTEM LOT TO BE ACCEPTABLE DURING MANUFACTURING AND PRIOR TO SHIPMENT. OUR INVESTIGATION WAS UNABLE TO REPRODUCE THE PERFORMANCE DESCRIBED IN THE FIELD SINCE THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. NOT RETURNED

    Description of Event or Problem · 1

    THE PATIENT HAD A PDA AND THE PHYSICIAN WANTED A 8/6 DUCT OCCLUDER AND THOUGH YOUR MEASURING CHART STATED THAT THIS DEVICE WOULD FIT THROUGH A 6F INTRODUCER AND IT APPARENTLY WAS INSERTED BUT COULDN'T BE RECOVERED THROUGH THE SHEATH AND THEY HAD TO USE A BAILOUT CATHETER. THEY PROCEEDED WITH ANOTHER 8/6 PDA AND CLOSED THE PDA SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER DUCT OCCLUDER CARDIAC OCCLUSION DEVICE MAE AGA MEDICAL CORPORATION 9-PDA-005 M08F02-50

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Required Intervention