BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION KIT

    MDR report key: 1191204 · Received September 26, 2008

    Report

    Report Number
    3005099803-2008-04866
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 29, 2008
    Report Date
    August 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE WILL BE RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED; 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 THERMODILATATION KIT WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, APPROX FIVE MINUTES INTO THE PROCEDURE, THE PROLIEVE SYSTEM DISPLAYED A "LOW WATER LEVEL" MESSAGE. THE PHYSICIAN FOUND THE PROSTHETIC DILATION BALLOON LEAKED. THE PROLIEVE CATHETER WAS REPLACED WITH A NEW PROLIEVE THERMODILATATION KIT, THE PROCEDURE COMPLETED SUCCESSFULLY. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION WAS REPORTED AS "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILITATION KIT MEQ BOSTON SCIENTIFIC CORPORATION M0068808022 0000606833

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK