BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER TORQVUE DELIVERY SYSTEM

    MDR report key: 1102843 · Received August 11, 2008

    Report

    Report Number
    2135147-2008-00021
    Event Type
    Injury
    Date Received
    August 11, 2008
    Date of Event
    February 5, 2008
    Report Date
    August 11, 2008
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY SYSTEM WAS NOT RETURNED FOR ANALYSIS, AND THE DELIVERY SYSTEM'S LOT NUMBER WAS NOT PROVIDED. THIS DEVICE WAS USED IN ASSOCATION WITH THE DEVICE IN 2135147-2008-00020.

    Description of Event or Problem · 1

    A VSD-MUSC-004 WAS REPORTED TO BE INCOMPATIBLE WITH THIS 6FR TORQVUE DEIVERY SYSTEM. THE PROCEDURE WAS STOPPED DUE TO INCREASING BLOOD LOSS OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER TORQVUE DELIVERY SYSTEM DELIVERY SYSTEM MLV AGA MEDICAL CORPORATION 9-ITV06F180/80 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention