BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 1822329 · Received September 1, 2010

    Report

    Report Number
    3005099803-2010-03810
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THE DEVICE WAS DISPOSED OF. 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 ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN WAS UNABLE TO OBTAIN A CERVICAL SEAL BECAUSE THE PATIENT HAD A LOOSE CERVIX. THE HTA PROCEDURE WAS DISCONTINUED AT THIS POINT. UPON ADDITIONAL FOLLOW UP WITH THE PHYSICIAN, IT IS REPORTED THAT THE PATIENT DID NOT HAVE A PATULOUS CERVIX AND HAD PREVIOUS VAGINAL BIRTHS WHICH CAUSED THE CERVIX TO BE LOOSE. A CERVICAL LEAK OCCURRED DURING THE PROCEDURE. HOWEVER, A BURN DID NOT OCCUR. NO ALARM OR ERROR MESSAGES WERE GENERATED. THE PROCEDURE COULD NOT BE COMPLETED DUE TO THESE CONDITIONS. THERE WERE NO FURTHER COMPLICATIONS REPORTED WITH THIS EVENT AND 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 M006560210 39624

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR