BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEGADE

    MDR report key: 3231134 · Received June 26, 2013

    Report

    Report Number
    3231134
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    RENEGADE CATHETER WAS REMOVED FROM HOUSING AND FOUND TO BE KINKED BEFORE USE. EQUIPMENT DID NOT REACH THE PATIENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289890 RENEGADE CATHETER KRA BOSTON SCIENTIFIC 18-302 15877971

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR