BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION KIT

    MDR report key: 1181617 · Received September 25, 2008

    Report

    Report Number
    3005099803-2008-04838
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 26, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE PROLIEVE THERMODILITATION KIT IS NOT KNOWN; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CANNOT BE DETERMINED. THE LOT NUMBER PROVIDED BY THE COMPLAINANT REPRESENTS THE PROLIEVE CATHETER; A PART OF THE KIT. THE DEVICE HAS NOT BEEN RETURNED, 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

    PLEASE NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES THAT WERE USED DURING THE SAME PROCEDURE. REFER TO MFR REPORT # 3005099803-2008-04839 FOR A DESCRIPTION OF THE FIRST DEVICE. IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A PROLIEVE THERMODILITATION KIT WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE THE DAY PRIOR. ACCORDING TO THE COMPLAINANT, APPROXIMATELY TWENTY-FIVE MINUTES INTO THE PROCEDURE, THERE WAS A LOW WATER LEVEL ERROR. THEY NOTICED THE ANCHORING BALLOON HAD NO WATER IN IT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS ISSUE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION WAS REPORTED AS "OKAY."

    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