BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1242985 · Received November 20, 2008

    Report

    Report Number
    3005099803-2008-06606
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE USED IS UNKNOWN, CONSEQUENTLY THE DEVICE MANUFACTURING AND EXPIRATION DATES ARE UNKNOWN. INFORMATION WAS COMPLETED BY THE MANUFACTURER BASED ON INFORMATION OBTAINED FROM THE USER FACILITY. THE SUSPECT DEVICE HAS BEEN DISPOSED. A DEVICE EVALUATION WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A HTA PROCEDURE USING THE HYDROTHERMABLATOR PROCEDURE SET, THERE WAS FLUID LOSS. THE PROCEDURE STARTED WELL AND A GOOD SEAL APPEARED TO HAVE BEEN ESTABLISHED. TWO TENACULUMS, AND TWO LONG ALICES WERE IN PLACE; TENACULUM STABILIZER WAS NOT USED. APPROXIMATELY HALF-WAY THROUGH THE PROCEDURE (5 MINUTES 15 SECONDS), THE DEVICE ALARMED; THE PHYSICIAN NOTICED FLUID COMING OUT OF THE CERVIX. THE FLUID LOSS WAS AT APPROXIMATELY 10 CC LOSS ALARM AT 40 CC PER MINUTE. THE PHYSICIAN APPLIED SALINE TO THE AREA TO COOL DOWN THE PATIENT. THE MANUFACTURER REPRESENTATIVE PRESENT IN THE CASE RECOMMENDED THE PROCEDURE BE STOPPED. A SMALL 1ST DEGREE BURN OR LESS, APPROXIMATELY THE SIZE OF A PENCIL ERASER, WAS OBSERVED ON THE CERVIX. SILVADENE CREAM WAS APPLIED. PATIENT CONDITION IS REPORTED AS "FINE".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention