BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1241269 · Received November 21, 2008

    Report

    Report Number
    3005099803-2008-06680
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 24, 2008
    Report Date
    October 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT IS DISPOSED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SECTION A: AGE AND WEIGHT - UNKNOWN. A HYDROTHERMABLATOR PROCEDURE SET WAS USED DURING THE HYDRO THERMABLATOR (HTA) PROCEDURE. A TENACULUM STABILIZER AND SPECULUM WAS USED. THE CLINICIAN DID NOT NOTICE ANY FLUID LEAKS DURING HYSTEROSCOPY. THERE WAS NO EXCESSIVE MOVEMENT OF THE SHEATH DURING THE ABLATION. THE FIRST FLUID ALARM WENT OFF AT 5 MINUTES AND 30 SECONDS REMAINING IN THE CASE. THE RATE OF LOST FLUID AT THE TIME OF THE ALARM WAS 10CC FLUID AT 1CC PER MINUTE. THERE WAS ONLY ONE FLUID LOSS ALARMS OCCURRED DURING THE PROCEDURE. THE PATIENT STARTED BUCKING ON THE TABLE WITH PROBABLY ABOUT 15 SECONDS. THE CASE WAS STOPPED. THE PHYSICIAN COMPLETED THE PROCEDURE AT 9 MINUTES AND 45 SECONDS. THE CIRCUMFERENCE OF A DIME SIZE BURN WAS FOUND TO BE ON THE LEFT SIDE BY THE CERVIX. THE PHYSICIAN ASSESSED THE BURN AS A FIRST DEGREE. THE CLINICIAN TREATED THE BURN WITH SILVADENE CREAM. THE PATIENT WAS NOT AWAKENED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROTHERMABLATOR PROCEDURE SET MNB BOSTON SCIENTIFIC CORPORATION M006560201 000034667

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other