BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHINOBI SGW

    MDR report key: 523947 · Received May 5, 2004

    Report

    Report Number
    1016427-2004-00040
    Event Type
    Injury
    Date Received
    May 5, 2004
    Date of Event
    April 6, 2004
    Report Date
    May 4, 2004
    Manufacturer
    CORDIS CORP (MIAMI)
    Product Code
    DQX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    GUIDEWIRE DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHINOBI SGW CARDIOLOGY WIRES & METALS DQX CORDIS CORP (MIAMI) NA A1103658

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R BMW GUIDEWIRE, GUIDANT JL4 GUIDING CATHETER, AND| AN OPENSALE DILATATION CATHETER.