BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDIS INTRODUCER

    MDR report key: 864012 · Received June 6, 2007

    Report

    Report Number
    MW5002551
    Event Type
    Injury
    Date Received
    June 6, 2007
    Date of Event
    May 9, 2007
    Report Date
    June 6, 2007
    Manufacturer
    ARROW
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE PLACEMENT OF CORDIS INTRODUCER FROM L. IJ APPROACH, THE WIRE PARTIALLY BROKE. THE WIRE BROKE AFTER THE CORDIS INTRODUCER CATHETER WAS IN PLACE AND WE WERE ATTEMPTING TO REMOVE THE WIRE AND WE FELT THE WIRE BREAK AND REMOVED EVERYTHING AT ONCE. THE WIRE CAME OUT INTACT, BUT WAS CLEARLY PARTIALLY BROKEN. THE MANUFACTURER NEEDS TO BE NOTIFIED OF THE DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDIS INTRODUCER CORDIS INTRODUCER DYB ARROW AK-09903-S RF6126997

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Disability