BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIEVE THERMODILATATION KIT

    MDR report key: 1061330 · Received June 13, 2008

    Report

    Report Number
    3005099803-2008-00726
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    April 24, 2008
    Report Date
    May 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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

    ON MAY 15, 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THAT ON THE PREVIOUS MONTH, A PROCEDURE USING A PROLIEVE THERMODILATATION KIT TO TREAT BENIGN PROSTATIC HYPERPLASIA (BPH) OCCURRED ON A MALE PATIENT (AGE AND WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, THE PHYSICIAN HAD DIFFICULTY PLACING THE PROLIEVE SYSTEM KIT CATHETER. THE PHYSICIAN THEN USED A SCOPE TO ADVANCE THE WIRE INTO THE BLADDER AND PLACED THE CATHETER OVER THE WIRE. REPORTEDLY, AFTER THE PROCEDURE, THE PT WAS UNABLE TO VOID AND WAS CATHERIZED. THE PHYSICIAN IRRIGATED THE BLADDER AND NOTICED "SUBSTANTIAL" BLEEDING. THE PT WAS THEN TAKEN TO THE HOSPITAL AND REMAINED UNTIL THE FOLLOWING FIVE DAYS. REPEATED ATTEMPTS TO RECEIVE UPDATES ON PATIENT'S CONDITION POST HOSPITALIZATION HAVE BEEN UNANSWERED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O