BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 1903422 · Received November 19, 2010

    Report

    Report Number
    3005099803-2010-04800
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    NORTH AMERICAN STERILIZATION &
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE DEVICE WAS DISPOSED OF AND IS NOT AVAILABLE FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED IN A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, TWO FLUID LOSS ALARMS, BOTH AT 60 CC/MIN, OCCURRED DURING THE HEATING PHASE. A LEAK WAS OBSERVED WHERE THE ADAPTER AND SHEATH CONNECT. ADDITIONALLY, THE PURPLE TUBING WAS COLLAPSED. THE SALINE IS REPORTED TO HAVE ONLY HEATED TO 40 DEGREES, AND NO CERVICAL LEAKS OR BURNS WERE SUSTAINED. THERE WAS NO INDICATION OF OVER DILATION, AND THERE WAS NOTHING UNUSUAL ABOUT THE CERVIX. THERE WAS ALSO NO TISSUE IN THE TUBING AT THE TIME OF THE PROBLEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECOND HYDROTHERMABLATION PROCERVA PROCEDURE SET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE IS 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 NORTH AMERICAN STERILIZATION & M006560211 0000039297

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR