BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION KIT

    MDR report key: 1172924 · Received September 19, 2008

    Report

    Report Number
    3005099803-2008-04737
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE PROLIEVE THERMODILITATION KIT IS NOT KNOWN; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CANNOT BE DETERMINED. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A PROLIEVE THERMODILITATION KIT WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, APPROXIMATELY FIFTEEN MINUTES INTO THE PROCEDURE, THERE WAS A LOT WATER LEVEL READING AND IT IS SUSPECTED IT MAY BE A LEAKY DILATATION BALLOON. THE NURSE WAS ABLE TO MAINTAIN THE WATER LEVEL BY CONSTANTLY REFILLING THE CARTRIDGE, AND WAS ABLE TO COMPLETE TO PROCEDURE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION WAS REPORTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILITATION KIT MEQ BOSTON SCIENTIFIC CORPORATION M0068808022 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK