BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILATATION SYSTEM

    MDR report key: 1551773 · Received November 24, 2009

    Report

    Report Number
    3005099803-2009-05593
    Event Type
    Malfunction
    Date Received
    November 24, 2009
    Date of Event
    June 3, 2009
    Report Date
    June 8, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE, A PROLIEVE THERMODILATATION SYSTEM, REFURBISHED, WAS EVALUATED INITIALLY ON SITE, BUT THEN WAS SENT TO SANMINA FOR ANALYSIS. THE REPORTED COMPLAINT WAS NOT CONFIRMED. THE CONSOLE FAILED THE RF OUTPUT TEST AND THE RF CONTROL BOARD WAS RECALIBRATED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROLIEVE THERMODILATATION SYSTEM WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE. A LOW-WATER LEVEL ERROR MESSAGE WAS DISPLAYED DURING THE CASE EVEN THOUGH THE HEAT EXCHANGER APPEARED FULL. REPLACING THE DISPOSABLE KIT DID NOT RESOLVE THE ISSUE. THE PATIENT RECEIVED 25 MINUTES OF TREATMENT. FOLLOW UP WITH THE COMPLAINANT REVEALED THE PATIENT IS "FINE". NOTE: THE EVENT, AS REPORTED, DID NOT REFLECT AN MDR-REPORTABLE SCENARIO. HOWEVER, EVALUATION OF THE RETURNED DEVICE REVEALED AN MDR-REPORTABLE MALFUNCTION OF "FAILED RF OUTPUT TEST". THE MDR IS BASED UPON THE EVALUATION RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILATATION SYSTEM MEQ BOSTON SCIENTIFIC CORPORATION M006880806R0

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR