BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIEVE THERMODILATATION KIT

    MDR report key: 1032798 · Received April 23, 2008

    Report

    Report Number
    3005099803-2008-00373
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    March 23, 2008
    Report Date
    March 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; AS IT WAS DISPOSED OF BY THE USER FACILITY, 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 MARCH 25, 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MALE PATIENT UNDERWENT TREATMENT WITH A PROLIEVE THERMODILATATION KIT IN 2008 AS PART OF A POST-MARKET STUDY USING PROLIEVE FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH). THE PATIENT WENT TO THE EMERGENCY ROOM AT MEDICAL CENTER SIX DAYS LATER, DUE TO CHILLS AND GENERALIZED BODY ACHES. IN THE ER, THE PATIENT WAS NOTED TO HAVE A FEVER OF 101 DEGREE AND A URINARY TRACT INFECTION ON THE URINALYSIS. THE PATIENT WAS ADMITTED, A FOLEY CATHETER WAS PLACED AND 500MG OF LEVAQUIN IV (DAILY) WAS INITIATED. BASED ON A UROLOGY CONSULTATION, THE PATIENT HAD URINARY TRACT SYMPTOMS. UROSEPSIS WAS DIAGNOSED CLINICALLY. ON THE DAY OF DISCHARGE, THREE DAYS LATER, THE PATIENT FELT WELL. THE FOLEY CATHETER WAS REMOVED AND THE PATIENT URINATED NORMALLY. ACCORDING TO THE COMPLAINT, THE INFECTION RESOLVED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILATATION KIT MEQ BOSTON SCIENTIFIC CORPORATION M0068808022 0000605285

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention