BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION KIT

    MDR report key: 1193352 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05121
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE PROLIEVE THERMODILITATION KIT IS NOT KNOWN; THEREFORE, THE DEVICE MFR DATE AND EXPIRATION DATE CANNOT BE DETERMINED. HOWEVER, LOT NUMBER 615495, PROVIDED BY THE COMPLAINANT REPRESENTS THE PROLIEVE CATHETER CONTAINED IN THE PROLIEVE THERMODILITATION KIT. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISCARDED, AND WILL NOT BE RETURNED FOR EVAL; 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

    ON SEPT 9, 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A PROLIEVE THERMODILITATION KIT WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE COMPRESSION BALLOON LEAKED AND WAS UNABLE TO MAINTAIN WATER PRESSURE. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE BY REFILLING THE CARTRIDGE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION WAS REPORTED AS "FINE".

    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