BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIEVE THERMODILATATION KIT

    MDR report key: 951130 · Received November 21, 2007

    Report

    Report Number
    6000154-2007-00004
    Event Type
    Injury
    Date Received
    November 21, 2007
    Date of Event
    June 22, 2007
    Report Date
    June 22, 2007
    Manufacturer
    ACCELLENT INC.
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED BY THIS MFR. AN EVALUATION HAS NOT BEEN PERFORMED, 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. THE MAY 2007 15-MONTH MICROWAVE DISPOSABLE DEVICES COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURES MODES WAS REVIEWED; NO ADVERSE TRENDS WERE NOTED AND NO DATA POINT EXCEEDED THE COMPLAINT ALERT LIMIT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS INTENDED TO REPLACE MFR REPORT # 6000043-2007-00093. IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A PROLIEVE THERMODILATATION KIT WAS USED FOR THERAPEUTIC PURPOSES IN THE URETHRA IN 2007. DURING THE PROCEDURE, THE WATER TEMPERATURE WAS GIVING INTERMITTENT READINGS BETWEEN HIGH AND LOW TEMPERATURES (60 DEGREES CELSIUS TO -1 CELSIUS). THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. POST PROCEDURE, THE PATIENT WAS HAVING DIFFICULTY VOIDING. DURING PLACEMENT OF THE CATHETER, THE PHYSICIAN NOTICED A "SIGNIFICANT AMOUNT OF BLOOD IN THE URINE". THE PATIENT THEN PROCEEDED TO PASS OUT AS RESULT OF LOW BLOOD PRESSURE. OXYGEN WAS ADMINISTERED AND A CALL WAS PLACED TO 911. PATIENT GAINED CONSCIOUSNESS AND CLAIMED TO FEEL FINE BUT WAS BROUGHT TO THE EMERGENCY ROOM UPON THE DAUGHTER'S REQUEST. THE PATIENT IS OVER 80 YRS OF AGE. DIABETIC AND HAD NOT EATEN FOR APPROX 12 HRS PRIOR TO THE PROCEDURE. DURING A PATIENT FOLLOW UP VISIT, IN THE HOSPITAL, THE PHYSICIAN NOTED URETHRAL TRAUMA WITH BLEEDING AT THE BLADDER NECK. THE METHOD OF TREATMENT USED WAS CAUTERIZATION WHICH STOPPED THE BLEEDING. THE PATIENT IS FINE AND WAS EXPECTED TO BE DISCHARGED IN THE NEXT FIVE DAYS. IT IS THE PHYSICIAN'S OPINION THAT THE DESIGN OF THE PROLIEVE CATHETER CAUSED THE TRAUMA DUE TO STIFFNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILATATION KIT MEQ ACCELLENT INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R PROLIEVE THERMODILITATION SYSTEM 688-080