BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 2223424 · Received August 25, 2011

    Report

    Report Number
    3005099803-2011-02829
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 OF AND THE DEVICE WILL NOT BE RETURNED. 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 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 PERFORMED ON (B)(6), 2011. (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, IT WAS REPORTED THAT AN ESSURE PROCEDURE WAS PERFORMED PRIOR TO THE HTA PROCEDURE. DURING THE ESSURE PROCEDURE, IT WAS REPORTED THAT 2000 CC'S OF FLUID WAS LEAKING ONTO THE GROUND FROM THE PATIENT'S STOMACH. THE PHYSICIAN PROCEEDED WITH THE HTA PROCEDURE AND COMPLETED THE CASE WITH ZERO FLUID LOSS ALARM ERROR MESSAGES. IT WAS NOT CONFIRMED WHETHER OR NOT A UTERINE PERFORATION OCCURRED. ADDITIONAL FOLLOW UP INFORMATION FROM THE PHYSICIAN CONFIRMED THAT THE ESSURE PROCEDURE WAS PERFORMED PRIOR TO THE HTA PROCEDURE. NO FLUID LOSS ALARM ERROR MESSAGE OCCURRED AND NO CERVICAL LEAK OCCURRED DURING THE HTA PROCEDURE. IMMEDIATELY FOLLOWING BOTH PROCEDURES, THE PATIENT EXPERIENCED ABDOMINAL DISTENTION. THE PHYSICIAN PERFORMED AN EXPLORATORY LAPAROSCOPY UPON WHICH A 4 MM UTERINE PERFORATION WAS NOTICED IN THE POSTERIOR UTERINE WALL. IT IS UNABLE TO BE DETERMINED WHICH DEVICE CAUSED THE UTERINE PERFORATION. NO TREATMENT WAS ADMINISTERED TO THE UTERINE PERFORATION. IN ADDITION, APPROXIMATELY 1200 - 1500 CC'S OF ROOM TEMPERATURE FLUID WAS OBSERVED IN THE PATIENT'S CAVITY. THE FLUID WAS NOT MANUALLY REMOVED FROM THE PATIENT'S CAVITY. THE PATIENT WAS HOSPITALIZED FOR OBSERVATION AND PAIN MANAGEMENT ON (B)(6), 2011 AND RELEASED ON (B)(6), 2011. THE PATIENT WAS GIVEN THE ANTIBIOTICS CLINDAMYCIN AND ANCEF TO TAKE AT HOME ONCE RELEASED FROM THE HOSPITAL. THE ANTIBIOTICS WERE ADMINISTERED TO PREVENT INFECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED WITH THIS EVENT. THE CONDITION OF THE PATIENT IS REPORTED TO BE "OK."

    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 35 YR Hospitalization| R