BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION SYSTEM

    MDR report key: 1616284 · Received February 26, 2010

    Report

    Report Number
    3005099803-2010-00698
    Event Type
    Malfunction
    Date Received
    February 26, 2010
    Date of Event
    June 2, 2009
    Report Date
    February 4, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE, A PROLIEVE THERMODILATATION SYSTEM, REFURBISHED, WAS SENT TO SANMINA FOR ANALYSIS. EVALUATION RESULTS STATE THE PRESSURE FAILED DUE TO A DEFECTIVE SENSOR BOARD AND RADIO FREQUENCY (RF) OUT OF SPECIFICATION WAS DUE TO A DEFECTIVE Q1 ON RF CONTROL BOARD. THE MALFUNCTIONS WERE ADDRESSED BY REPLACING THE SENSOR BOARD, RF OUTPUT MODULE AND RF CONTROL BOARD. IN ADDITION, THE FOLLOWING WERE ALSO REPLACED: DEFECTIVE PELTIERS IN THE HEAT EXCHANGER MODULE FAN, BROKEN FAN ON HEAT EXCHANGER MODULE AND DEFECTIVE PHYSITEMPS 1 & 3.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROLIEVE THERMODILATATION SYSTEM, REFURBISHED, WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE. A BSC SALES REPRESENTATIVE CALLED INTO TECHNICAL SERVICES DURING THE TREATMENT TO REPORT A PROBLEM WITH PROLIEVE UNIT; THERE WAS NOT ENOUGH PRESSURE DURING THE TREATMENT. THE SYSTEM PUMP SPEED WAS UP TO 50 BEFORE IS REACHED ~10 PSI. THE CASE WAS COMPLETED WITH NO PATIENT ISSUES. PER FOLLOW UP WITH THE COMPLAINANT, THE PATIENT CONDITION IS GOOD. NOTE: THE EVENT, AS REPORTED, DID NOT REFLECT AN MDR-REPORTABLE SCENARIO. HOWEVER, EVALUATION OF THE RETURNED CONSOLE REVEALED AN MDR-REPORTABLE MALFUNCTION OF "RADIO FREQUENCY (RF) OUT OF SPECIFICATION". THE MDR IS BASED UPON THE EVALUATION RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILITATION SYSTEM SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY MEQ BOSTON SCIENTIFIC - MARLBOROUGH M006880806R0

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR