BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 2063153 · Received April 19, 2011

    Report

    Report Number
    3005099803-2011-01208
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE UPN AND 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 FILED.

    Description of Event or Problem · 1

    A HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED DURING A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT RECEIVED A VAGINAL BURN DURING THE PROCEDURE. FLUID LEAKAGE WAS OBSERVED AT THE CERVIX WHICH PROMPTED THE PHYSICIAN TO NOTICE THE VAGINAL BURN. TOPICAL CREAM WAS APPLIED TO THE BURN. ADDITIONAL FOLLOW UP INFORMATION FROM THE PHYSICIAN REPORTED THAT A FLUID LOSS ALARM ERROR MESSAGE GENERATED ON THE SYSTEM AT A RATE OF 10 CC'S PER MINUTE. THE PATIENT WAS NOT DILATED BEYOND 8 MM. THE PATIENT HAD A SUB-MUCOSAL FIBROID TUMOR WHICH WAS REMOVED PRIOR TO THE HTA PROCEDURE. A CERVICAL LEAK OCCURRED DURING THE PROCEDURE. THE LOCATION OF THE BURN RANGED FROM THE POSTERIOR END TO THE RIGHT POSTERIOR END OF THE VAGINA AND THE SHAPE RESEMBLED A FIGURE EIGHT. THE SIZE OF THE BURN RANGED FROM 3 1/2 X 2 CM TO 2 CM X 2 CM IN SIZE. THE BURN WAS FIRST DEGREE IN SEVERITY. PREMARIN CREAM WAS ADMINISTERED TO THE AFFECTED AREA AS TREATMENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED WITH THIS EVENT. ADDITIONAL 21-DAY FOLLOW UP EVENT INFORMATION FROM THE CLINICIAN REPORTED THE PATIENT HAD A POST-OPERATIVE VISIT WITH THE PHYSICIAN. THE PATIENT REPORTED SCANT BLEEDING FOLLOWING THE HTA PROCEDURE. THE PATIENT IS NOT EXPERIENCING ANY PAIN AND HAS NORMAL BLADDER AND BOWEL FUNCTIONS. NO PROBLEMS WITH THE OUTER VAGINAL AREA WERE REPORTED BY THE PATIENT. THE PHYSICIAN PERFORMED A PELVIC EXAM AND FOUND NO LESIONS ON THE LABIA MAJORA AND LABIA MINORA. THE MUCOSAL SURFACE WAS INTACT WITH NO EROSION. THE PATIENT IS REPORTED TO BE "DOING WELL" AND HAS BEEN INSTRUCTED TO NOTIFY THE PHYSICIAN IF ANY CHANGES TO THE MENSTRUAL CYCLE OCCUR.

    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 UNK560

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention