BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILATATION KIT

    MDR report key: 1181609 · Received September 25, 2008

    Report

    Report Number
    3005099803-2008-04855
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 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 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 FIRST OF TWO DEVICES THAT WERE USED DURING THE SAME PROCEDURE. REFER TO MFR REPORT # 3005099803-2008-04854 FOR A DESCRIPTION OF THE SECOND DEVICE. A PROLIEVE THERMODILITATION KIT WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, APPROXIMATELY TWENTY-NINE MINUTES INTO THE PROCEDURE, THE PROLIEVE CATHETER'S PROSTHETIC BALLOON LEAKED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION WAS REPORTED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILATATION KIT MEQ BOSTON SCIENTIFIC CORPORATION M0068808022 0000607015

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR