BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPHROMAX

    MDR report key: 3242305 · Received July 9, 2013

    Report

    Report Number
    3242305
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    THE BALLOON FOR THE KIT IS SMALLER THAN THE SHEATH PROVIDED. WHEN THE TRACT IS DILATED WITH THE BALLOON, THE SHEATH IS NOT ABLE TO EASILY SLIDE OVER THE BALLOON TO CREATE THE OPERATIVE CHANNEL.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LEFT PERCUTANEOUS NEPHROLITHOTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314025 NEPHROMAX CATHETER, NEPHROSTOMY EZN BOSTON SCIENTIFIC 210-118 16134089

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR