BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1203289 · Received October 17, 2008

    Report

    Report Number
    3005099803-2008-05369
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    DURING THE HYDRO THERMABLATOR (HTA) PROCEDURE IN THE UTERUS A HYDRO THERMABLATOR PROCEDURE SET WAS USED. THE HOSE WAS LEAKING, NOT AT ANY CONNECTION POINT, BUT FROM A CRACK IN THE HOSE ITSELF. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE WITH NO PT COMPLICATIONS. IT IS UNKNOWN THAT WHEN DURING THE PROCEDURE AND WHERE ON THE HOSE THE LEAK OCCURRED. THE PT'S CONDITION IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROTHERMABLATOR PROCEDURE SET MNB BOSTON SCIENTIFIC CORPORATION M006560201 0000034679

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR