BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 1904440 · Received November 22, 2010

    Report

    Report Number
    3005099803-2010-04743
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER, THEREFORE, EXPIRATION AND MANUFACTURING DATES CANNOT BE DETERMINED. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT HAS BEEN DISPOSED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THIS EVENT. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED DURING A HYDROTHERMABLATION (HTA) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PATIENT SUDDENLY MOVED AND THEN COUGHED. AS A RESULT, FLUID WAS OBSERVED AT THE UTERUS AND THE SMALL PARTS OF THE BUTTOCK'S WERE BLISTERED. CLINICAL FOLLOW UP INFORMATION REVEALED THAT A TENACULUM WAS USED TO MAINTAIN A CERVICAL SEAL AND A TENACULUM STABILIZER WAS ALSO USED, THE BURN WAS CATEGORIZED AS "2ND DEGREE", A FLUID LOSS ALARM WAS GENERATED AT 10 CC'S, BURNS WERE BOTH INTERNAL AND EXTERNAL AND BURNS WERE TREATED WITH LIDOCAINE AND SILVADENE CREAM. THERE WERE NO FURTHER PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "OK". AN ADDITIONAL ATTEMPT HAS BEEN MADE TO OBTAIN FOLLOW UP EVENT DETAILS WITH NO RESPONSE FROM THE CLINICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - MARLBOROUGH M006560211

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention