BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIEVE THERMODILATATION KIT

    MDR report key: 1143711 · Received August 29, 2008

    Report

    Report Number
    3005099803-2008-04227
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE, A PROLIEVE THERMODILATATION KIT WAS NOT RETURNED FOR EVAL. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    ON JULY 30, 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROLIEVE THERMODILATATION KIT WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE ON EIGHT DAYS EARLIER. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS A LOW-LEVEL ERROR MESSAGE AND THE COMPRESSION BALLOON HAD A LEAK. LATER THAT NIGHT, THE PT EXPERIENCED URINARY RETENTION AND WENT TO THE EMERGENCY ROOM (FACILITY UNKNOWN). A FOLEY CATHETER WAS PLACED AND SUBSEQUENTLY REMOVED A WEEK LATER AT A FOLLOW-UP VISIT. THE PATIENT'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 UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O