BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOHNSON AND JOHNSON

    MDR report key: 3233837 · Received July 15, 2013

    Report

    Report Number
    MW5030911
    Event Type
    Injury
    Date Received
    July 15, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 9, 2013
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WIRE BROKE IN PATIENTS CORONARY ARTERY. PREVIOUSLY PLACED STENT WAS OCCLUDED. ATW WIRE WAS PLACED IN THE LAD, AND 9/10 OF THE WAY THROUGH THE STENT. COULD NOT ADVANCE THE WIRE FURTHER. REMOVED THE ATW WIRE, AND ADVANCED A SHINOBI WIRE. WAS ABLE TO CROSS STENT OCCLUSION WITH SHINOBI. AT THAT TIME REALIZED PREVIOUSLY UNRECOGNIZED FRAGMENT OF THE ATW WIRE EMBOLIZED FROM THE CATHETER. RETRIEVED WITH SNARE. NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326776 JOHNSON AND JOHNSON ATW GUIDEWIRE DQX 595-EX014

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention