BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION KIT

    MDR report key: 1171417 · Received September 17, 2008

    Report

    Report Number
    3005099803-2008-04645
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 18, 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
    PHYSICIAN ASSISTANT

    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. 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. A PRODUCT EVALUATION IS PENDING; RESULTS WILL BE PROVIDED IN A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROLIEVE THERMODILITATION KIT WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE THREE DAYS PRIOR. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE MACHINE SHUT OFF AT 28 MINUTES DUE TO A LOW WATER PRESSURE ALARM. THE PHYSICIAN'S ASSISTANT WAS ABLE TO CONTINUE THE PROCEDURE BY REFILLING THE CARTRIDGE WITH WATER. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THE PATIENT'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 M00068808022 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK