BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 2023640 · Received March 18, 2011

    Report

    Report Number
    3005099803-2011-00701
    Event Type
    Injury
    Date Received
    March 18, 2011
    Report Date
    February 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER (B)(6) PROVIDED BY THE END USER COULD NOT BE CONFIRMED; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE 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 ID, DATE OF BIRTH, AND WEIGHT ARE UNKNOWN.) ACCORDING TO THE COMPLAINANT, A "SMALL BURN-MARK" WAS OBSERVED OUTSIDE THE UTERUS POST HTA PROCEDURE. THE ATTENDING PHYSICIAN CONFIRMED DURING FOLLOW UP, THAT SHE PERFORMED A POLYPECTOMY PRIOR TO THE HTA PROCEDURE, RESULTING IN A "GOOD OUTCOME." SUBSEQUENTLY, THE HTA PROCEDURE WAS INITIATED AND COMPLETED WITH THE PATIENT RETURNING COMPLAINING OF STOMACH PAIN WITH AN INDICATION OF POSSIBLE INFECTION. A LAPAROSCOPY WAS PERFORMED TO EXCLUDE APPENDICITIS WHICH WAS CONFIRMED. SURGERY WAS PERFORMED AND "CHANGES" AT THE SIGMOIDEUM (SIGMOID COLON) AREA AGAINST THE UTERINE WALL WERE FOUND. EXACT SIZE AND SEVERITY ARE UNKNOWN. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND RELEASED FROM THE HOSPITAL ON (B)(6) 2011. INITIAL PATIENT HOSPITALIZATION DATE IS UNKNOWN. THERE WERE NO FURTHER COMPLICATIONS REPORTED WITH THIS EVENT AND THE CURRENT CONDITION OF THE PATIENT IS REPORTED TO BE "GOOD." AN ADDITIONAL ATTEMPT HAS BEEN MADE TO OBTAIN PATIENT FOLLOW UP DETAILS WITH NO RESPONSE FROM THE CLINICIAN TO DATE.

    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 UNK560

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R