BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILATATION KIT

    MDR report key: 1191201 · Received September 26, 2008

    Report

    Report Number
    3005099803-2008-04892
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    May 28, 2008
    Report Date
    August 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET 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. A PRODUCT EVALUATION IS PENDING; RESULTS WILL BE PROVIDED IN A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROLIEVE THERMODILATATION KIT WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROLIEVE THERMODILATATION KIT. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION WAS REPORTED AS "FINE." THREE MONTHS LATER, INVESTIGATION RESULTS REVEALED THAT WATER WAS LEAKING FROM THE COMPRESSION BALLOON, THEREFORE, MAKING THIS A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILATATION KIT MEQ BOSTON SCIENTIFIC CORPORATION M0068808022 0000606083

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK