BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1040208 · Received May 8, 2008

    Report

    Report Number
    3005099803-2008-00440
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE USED IS UNK, CONSEQUENTLY, THE MFR AND EXPIRATION DATE OF THE DEVICE IS UNK. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; AS IT WAS DISPOSED OF AND THEREFORE, A FAILURE ANALYSIS WAS NOT AVAILABLE. WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FEMALE (WEIGHT UNKNOWN) UNDERWENT A THERAPEUTIC HYDROTHERMAL ABLATION (HTA) PROCEDURE IN 2008. ACCORDING TO THE COMPLAINT, WHILE DILATING THE CERVIX, IT WAS NOTICED THAT THE CERVIX WAS VERY TIGHT. AS RESULT OF THIS, THE PHYSICIAN PUSHED HARDER AND PERFORATED THE PATIENT'S UTERUS. THE PHYSICIAN STATED THAT THE PERFORATION WAS EXTREMELY SMALL AND DID NOT REQUIRE ANY FORM OF INTERVENTION. THE ACTUAL SIZE WAS APPROXIMATELY 2 OR 3 CMS (SIZE OF THE DILATION TOOL). THE PHYSICIAN STOPPED THE PROCEDURE TO ENSURE THERE WOULD BE NO COMPLICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other