BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUSEE WIRE GUIDE WIRE

    MDR report key: 24603 · Received July 24, 1995

    Report

    Report Number
    24603
    Event Type
    Malfunction
    Date Received
    July 24, 1995
    Date of Event
    January 9, 1995
    Report Date
    February 28, 1995
    Manufacturer
    CORDIS CORP.
    Product Code
    DGX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    GUIDE WIRE FRACTURED DURING ATTEMPTED PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. DISTAL VESSEL COULD NOT BE BYPASSED. FRACTURED TIP RETAINED IN PLAQUE WALL AND COULD NOT BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUSEE WIRE GUIDE WIRE GUIDE WIRE DGX CORDIS CORP. 5J3-143 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR