BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 1953455 · Received January 10, 2011

    Report

    Report Number
    3005099803-2010-05467
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE PRODUCT HAS NOT YET BEEN RETURNED AND THE DEVICE HAS NOT YET BEEN EVALUATED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A CIRCON ACMI HYSTEROSCOPE ADAPTER WAS USED DURING A HYDROTHERMABLATION (HTA) PROCEDURE ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE HYSTEROSCOPY PHASE OF THE PROCEDURE, A LEAK WAS OBSERVED ORIGINATING FROM THE SCOPE ADAPTER. THE LEAK CONTINUED DURING THE ABLATION PHASE OF THE PROCEDURE. IN ADDITION, A FLUID LOSS ALARM ERROR MESSAGE OCCURRED AT 10 CC'S. THE CASE WAS COMPLETED WITH THE EXISTING SCOPE ADAPTER AND THE SALINE DID NOT CONTACT THE PATIENT. ADDITIONAL FOLLOW UP INFORMATION REPORTED THAT THE LEAK FROM THE SCOPE ADAPTER OCCURRED BETWEEN WHERE THE SCOPE ADAPTER CONNECTS TO THE SHEATH. THE TEMPERATURE OF THE SALINE STARTED AT 45 DEGREES AND CONTINUED TO LEAK AT 90 DEGREES CELSIUS. HOWEVER, THE SALINE WAS APPROXIMATELY 6 INCHES AWAY FROM THE PATIENT AND DID NOT CONTACT THE PATIENT. IT WAS CONFIRMED THAT NO CERVICAL LEAK OR BURN TO THE PATIENT OCCURRED DURING THE PROCEDURE. THERE WERE NO FURTHER COMPLICATIONS REPORTED WITH THIS EVENT. THE CONDITION OF THE PATIENT 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 BOSTON SCIENTIFIC - MARLBOROUGH M006550350

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR