BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION KIT

    MDR report key: 2153391 · Received August 21, 2008

    Report

    Report Number
    3005099803-2008-02044
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 5, 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 RETURNED DEVICE WAS VISUALLY INSPECTED AND NO APPARENT PHYSICAL DAMAGE OR IMPERFECTIONS WERE OBSERVED. DURING FUNCTIONALITY TESTING OF THE PROLIEVE CATHETER, A LEAK WAS FOUND IN THE COMPRESSION BALLOON. THE REPORTED COMPLAINT WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES. A LOT HISTORY SEARCH REVEALED NO ADD'L COMPLAINTS AGAINST THIS LOT. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A PROLIEVE THERMODILATATION KIT WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE. ACCORDING TO THE COMPLAINANT, THE BALLOON PRESSURE WOULD NOT FILL AFTER THE PROLIEVE CATHETER WAS PLACED. IT THEN GAVE A LOW WATER READING AND WATER CAME OUT OF THE URETHRA. THE PROLIEVE CATHETER WAS REMOVED AND TESTED BY TURNING ON THE PUMP TO FILL THE BALLOON. THE TEST REVEALED THAT THE BALLOON HAD A LEAK. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILITATION KIT MEQ BOSTON SCIENTIFIC CORPORATION M0068808022 0000605295

    Patients

    Seq Age Sex Outcome Treatment
    1