BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDEWIRE GUIDEWIRE .035/180

    MDR report key: 38384 · Received September 10, 1996

    Report

    Report Number
    1225056-1996-00001
    Event Type
    Injury
    Date Received
    September 10, 1996
    Date of Event
    August 10, 1996
    Report Date
    August 30, 1996
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ORIGINAL PROCEDURE WAS A SMALL MESENTERIC ANGIOGRAM. THE WIRE WAS USED THROUGH AN ENTRY NEEDLE. THE WIRE WAS REMOVED AND IT WAS NOTED APPROX 13CM OF THE COATING SHEARED AND DETACHED IN THE PT'S RIGHT GROIN. SURGICAL REMOVAL OF THE DETACHED COATING WAS UNEVENTFUL AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DIRECTIONS FOR USE FOR THIS PRODUCT STATE: "TO AVOID DAMAGE AND POSSIBLE SHEARING OF PLASTIC, DO NOT WITHDRAW OR MANIPULATE THROUGH A METAL CANNULA/METAL DILATOR NOR ADVANCE THE METAL CANNULA/METAL DILATOR. EXTREME CAUTION SHOULD BE OBSERVED WHEN USED WITH A ONEWALL PUNCTURE STYLE NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLIDEWIRE GUIDEWIRE .035/180 GUIDEWIRE DQX TERUMO MEDICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention