BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HTA SHEATH ASSEMBLY

    MDR report key: 1211846 · Received October 10, 2008

    Report

    Report Number
    1211846
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS DOING THE DIAGNOSTIC PORTION OF THE PROCEDURE; NO FLUIDS WERE FLUSHING TO THE UTERUS. FLUIDS WERE ACCUMULATING INTO THE SHEATH. SHEATH ASSEMBLY REPLACED. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HTA SHEATH ASSEMBLY ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC CORP. * 34870

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR