BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1242914 · Received November 19, 2008

    Report

    Report Number
    3005099803-2008-06567
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CORP WAS INFORMED THAT DURING THE HYSTEROSCOPY PHASE OF A HTA PROCEDURE, A LEAK WAS NOTICED IN THE SHEATH OF THE HYDROTHERMABLATOR PROCEDURE SET. THE LEAK WAS NOTICE WHERE THE TUBING MEETS THE SHEATH, NEAR THE ADAPTOR. A TENACULUM WAS IN USE DURING THE PROCEDURE. IT WAS REPORTED THAT DURING THE HYSTEROSCOPY EXCESSIVE MOVEMENT AND STRESS WAS PUT ON SHEATH. THE PHYSICIAN STATED THAT THE PT HAD A VERY LONG CERVIX REQUIRING HIM TO PUT A LOT OF PRESSURE ON THE SHEATH AND IT CRACKED. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE WITH NO PT COMPLICATIONS; THE PT IS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROTHERMABLATOR PROCEDURE SET MNB BOSTON SCIENTIFIC CORPORATION M006560201 0000034892

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK