BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION KIT

    MDR report key: 1133450 · Received August 22, 2008

    Report

    Report Number
    3005099803-2008-03789
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 23, 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

    THE LOT NUMBER OF THE DEVICE USED IS UNKNOWN; CONSEQUENTLY, THE EXPIRATION AND MANUFACTURER DATE OF THE DEVICE IS UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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

    IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THAT A PROCEDURE USING A PROLIEVE THERMODILITATION KIT FOR BENIGN PROSTATIC HYPERPLASIA (BPH) OCCURRED A DAY PRIOR. ACCORDING TO THE COMPLAINANT, APPROXIMATELY TWENTY MINUTES INTO THE PROCEDURE, A LOW WATER LEVEL ALARM WAS RECEIVED. THE PHYSICIAN DECIDED TO STOP THE PROCEDURE, AND DETERMINED THAT THE PATIENT HAD RECEIVED ENOUGH TREATMENT. THE PATIENT EXPERIENCED SOME BLEED WHEN THE PROLIEVE CATHETER WAS REMOVED. THE PHYSICIAN PLACED A FOLEY CATHETER (MANUFACTURER UNKNOWN). 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK