BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 3062662 · Received April 17, 2013

    Report

    Report Number
    3005099803-2013-02473
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM WAS USED IN A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2013. THE PATIENT WAS REPORTED TO BE FEMALE (NO ADDITIONAL PATIENT INFORMATION AVAILABLE). ACCORDING TO THE COMPLAINANT, THE CONSOLE WAS PLUGGED INTO THE VIDEO TOWER WHICH WAS PLUGGED INTO THE WALL. TWO MINUTES INTO THE ABLATION THE PHYSICIAN REPORTED THAT THERE WAS NO ABLATION, HOWEVER, WATER WAS NOTED TO BE CIRCULATING. ALMOST IMMEDIATELY AFTER THAT THE POWER WAS LOST TO THE CONSOLE AND THE VIDEO TOWER. THE SHEATH WAS LEFT IN PLACE AND THE CONSOLE WAS POWERED UP. THE PATIENT WAS COOLED AND ANOTHER PROCEDURE SET WAS INSTALLED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS REPORTED TO BE "FINE" AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165053 HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - FREMONT (CE) M006580010

    Patients

    Seq Age Sex Outcome Treatment
    1