BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 1924893 · Received December 14, 2010

    Report

    Report Number
    3005099803-2010-05044
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 OF AND THE DEVICE WILL NOT BE RETURNED. 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 SUBMITTED.

    Description of Event or Problem · 1

    A HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED DURING A HYDROTHERMABLATION (HTA) PROCEDURE ON (B)(6) 2010. (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, POST PROCEDURE, THE PHYSICIAN NOTED A BURN TO THE LABIA OF THE VAGINA. NO LEAKS WERE NOTED DURING THE PROCEDURE. THE PHYSICIAN TREATED THE BURN WITH SILVADENE CREAM AND RELEASED THE PATIENT. ADDITIONAL FOLLOW UP INFORMATION PROVIDED THAT A FIRST DEGREE BURN OCCURRED TO THE LABIA WHICH WAS OBSERVED POST PROCEDURE. THE SIZE OF THE BURN WAS APPROXIMATELY 3 CM. IT WAS CONFIRMED THAT THE PHYSICIAN USED SILVADENE CREAM AS TREATMENT TO THE AFFECTED AREA. A FLUID LOSS ALARM ERROR MESSAGE WAS NOT GENERATED ON THE SYSTEM, AND IT WAS CONFIRMED THAT A CERVICAL LEAK DID NOT OCCUR. THERE WERE NO FURTHER COMPLICATIONS REPORTED WITH THIS EVENT AND THE CONDITION OF THE PATIENT IS REPORTED TO BE FINE. AN ADDITIONAL ATTEMPT HAS BEEN MADE TO OBTAIN PATIENT FOLLOW UP DETAILS WITH NO RESPONSE FROM THE CLINICIAN.

    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 47 YR Required Intervention