BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW

    MDR report key: 22808 · Received July 26, 1994

    Report

    Report Number
    1930713-1994-00003
    Event Type
    Injury
    Date Received
    July 26, 1994
    Date of Event
    May 23, 1994
    Report Date
    May 25, 1994
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    MKI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE GIDEWIRE WAS BROKEN AT THE 41 CM MARK ONLY 4 CM FROM THE "J" TIP LEAVING THE FRAYED BROKEN WIRE IN THE SUBCUTANEOUS TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW Implant AK-09800 PERCUTANEOUS SHEATH MKI ARROW INTERNATIONAL, INC. AK-09800 AK-9-003-4

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention