BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION KIT

    MDR report key: 1160035 · Received September 12, 2008

    Report

    Report Number
    3005099803-2008-04542
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT EVALUATION IS PENDING; RESULTS WILL BE PROVIDED IN A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS THE FIRST OF TWO REPORTED MALFUNCTIONS OCCURRING DURING THE PROCEDURE. A PROLIEVE THERMODILITATION KIT WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE, IN 2008. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE ANCHORING BALLOON HAD A LEAK, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER PROLIEVE THERMODILITATION KIT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. REFER TO MFR REPORT #3005099803-2008-04541 FOR DETAILS REGARDING THE SECOND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILITATION KIT MEQ BOSTON SCIENTIFIC CORPORATION M0068808022 0000606602

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK