BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION KIT

    MDR report key: 1202218 · Received October 16, 2008

    Report

    Report Number
    3005099803-2008-05296
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 16, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT AN EVAL HAS NOT YET BEEN PERFORMED. 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, DURING THE PROCEDURE, THE PROLIEVE SYSTEM DISPLAYED A "WATER CARTRIDGE LEVEL LOW" ERROR MESSAGE AND THE ANCHORING BALLOON LEAKED. AFTER REFILLING THE WATER CARTRIDGE, THE PROBLEM PERSISTED AND THE PHYSICIAN DECIDED TO ABORT AND RESCHEDULE THE PROCEDURE. 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 0000607190

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR