BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGA

    MDR report key: 510548 · Received February 3, 2004

    Report

    Report Number
    510548
    Event Type
    Injury
    Date Received
    February 3, 2004
    Date of Event
    January 5, 2004
    Report Date
    February 3, 2004
    Manufacturer
    AGA MEDICAL CORP.
    Product Code
    DQT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AMPLATZ SEPTAL OCCLUDER, SIZE 30MM, WAS DEPLOYED. AFTER A 5 MINUTE WAIT, THE DEVICE EMBOLIZED IN THE LEFT ATRIUM. THIS SEEMED DUE TO THE FACT THERE WAS NO LIP FOR THE OCCLUDER TO REST ON. THE PT UNDERWENT SURGERY TO REMOVE THE OCCLUDER AND THE SURGEON THEN PROCEEDED TO REPAIR THE ASD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGA SEPTAL OCCLUDER DQT AGA MEDICAL CORP. * M03H19-44/9-2006

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention