BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION KIT

    MDR report key: 1160021 · Received September 12, 2008

    Report

    Report Number
    3005099803-2008-04520
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE PROLIEVE THERMODILITATION KIT IS NOT KNOWN; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CAN NOT BE DETERMINED. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND 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 PROLIEVE THERMODILITATION KIT WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE IN THE SAME MONTH. ACCORDING TO THE COMPLAINANT, APPROXIMATELY 25 MINUTES INTO THE PROCEDURE A "LOW WATER LEVEL" ERROR MESSAGE WAS DISPLAYED. THE PHYSICIAN CONTINUED TO POUR SALINE INTO THE CARTRIDGE AND WAS ABLE TO COMPLETE THE PROCEDURE. IT WAS ASSUMED BY THE USER THAT THE CATHETER WAS CAUSING THE PROBLEM AS THERE WAS NO WATER LOSS OUTSIDE OF THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. 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 M0068808022 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK