BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION KIT

    MDR report key: 1133503 · Received August 22, 2008

    Report

    Report Number
    3005099803-2008-03782
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT REPORTED THAT THE DEVICE HAS BEEN DISPOSED OF AND WILL NOT BE RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THAT A PROCEDURE USING A PROLIEVE THERMODILITATION KIT FOR BENIGN PROSTATIC HYPERPLASIA (BPH) OCCURRED. ACCORDING TO THE COMPLAINANT, THERE WAS A LEAK IN THE ANCHOR BALLOON; EVEN THOUGH, IT APPEARED TO BE FINE DURING PREPARATION AND THERE WERE NO FLUID LOSS ALARMS. DURING THE PROCEDURE, THE PROLIEVE CATHETER BECAME DISLODGED ( MIGRATED). THE PROCEDURE WAS COMPLETED WITH ANOTHER PROLIEVE THERMODILITATION KIT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILITATION KIT MEQ BOSTON SCIENTIFIC CORPORATION M0068808022 0000606782

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK