BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 1962269 · Received January 18, 2011

    Report

    Report Number
    3005099803-2011-00016
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 (PATIENT INITIALS AND BIRTH DATE ARE NOT KNOWN)ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING HYSTEROSCOPY, FLUID WAS OBSERVED LEAKING FROM THE CERVIX. A TENACULUM WAS ADDED ON THE SIDE AND PROCEDURE CONTINUED, NOTING THE LEAK HAD STOPPED. DURING INITIAL ABLATION, FLUID WAS OBSERVED ON THE RATEX AND THE SYSTEM WAS SHUT DOWN. NO BURNS WERE SUSTAINED SO THE PROCEDURE WAS RESTARTED. EVERYTHING LOOKED GOOD UNTIL ABOUT 4 MINUTES INTO THE ABLATION WHEN SOME FLUID FLUCTUATION OCCURRED. THE SHEATH AND THE RATEX GOT WET AGAIN. AT THIS TIME, THE PROCEDURE WAS ABORTED AND THE UNIT PROGRESSED INTO COOL DOWN. AGAIN, NO BURNS WERE SUSTAINED BUT SILVADENE CREAM WAS APPLIED AS A PRECAUTION. THERE WERE NO ALARMS GENERATED. CLINICAL FOLLOW UP INFORMATION RECONFIRMED THAT NO BURNS WERE SUSTAINED, THERE WERE NO ALARMS OR ERROR CODES, THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT'S ANATOMY, THE PATIENT WAS NOT ON CYCLE AND THE PATIENT DID NOT HAVE TO BE DILATED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE".

    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 39 YR