BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION KIT

    MDR report key: 1211334 · Received October 22, 2008

    Report

    Report Number
    3005099803-2008-05445
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT # OF THE PROLIEVE THERMODILITATION KIT IS NOT KNOWN; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CAN NOT BE DETERMINED. HOWEVER, LOT NUMBER 615447, PROVIDED BY THE COMPLAINANT REPRESENTS THE PROLIEVE CATHETER CONTAINED IN THE PROLIEVE THERMODILITATION KIT. THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION 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

    ON SEPTEMBER 22, 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A PROLIEVE THERMODILITATION WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DILATATION BALLOON POPPED DURING INFLATION AND THE BALLOON REMAINED ATTACHED TO THE PROLIEVE CATHETER. THE BALLOON WAS CONTAINED AND REMOVED FROM THE PT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER PROLIEVE THERMODILITATION KIT. 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