BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST JUDE MEDICAL

    MDR report key: 385084 · Received March 27, 2002

    Report

    Report Number
    MW1024503
    Event Type
    Injury
    Date Received
    March 27, 2002
    Date of Event
    March 4, 2002
    Report Date
    March 19, 2002
    Manufacturer
    DAIG DIV
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING AN ABDOMINAL ARTERIOGRAM PROCEDURE THROUGH THE LEFT BRACHIAL ARTERY. A 9MM TUBE PORTION OF THE ANGIOSEAL CLOSURE DEVICE WHICH IS INTENDED TO BE REMOVED WENT ENTIRELY UNDER THE SKIN AND HAD TO BE SURGICALLY REMOVED. THIS PIECE IS CALLED THE TEMPER TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL ANGIOSEAL MGB DAIG DIV 6F UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention