BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION KIT

    MDR report key: 1202219 · Received October 16, 2008

    Report

    Report Number
    3005099803-2008-05307
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE PROLIEVE THERMODILATATION KIT IS NOT KNOWN; THEREFORE, THE DEVICE MFR DATE AND EXPIRATION DATE CANNOT BE DETERMINED. THE DEVICE HAS BEEN RECEIVED, BUT AN EVAL 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

    IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A PROLIEVE THERMODILATATION KIT WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE A WEEK PRIOR. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PROLIEVE CATHETER WAS REMOVED AFTER THE PROCEDURE, IT WAS NOTICED THAT A METAL WIRE INSIDE THE CATHETER HAD POKED THROUGH THE CATHETER WALL. THE PROCEDURE WAS COMPLETED WITH THIS PROLIEVE THERMODILATATION KIT. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION WAS REPORTED AS "FINE" AND NO PERFORATIONS WERE NOTED.

    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