BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 2820217 · Received November 6, 2012

    Report

    Report Number
    3005099803-2012-05096
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS NOT KNOWN PER COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CAN NOT BE DETERMINED. DEVICE AVAILABLE FOR EVALUATION: DEVICE DISPOSED OF. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISPOSED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDROTHERMABLATION (HTA) PROCERVA PROCEDURE SET WAS USED DURING AN HTA PROCEDURE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, AT APPROXIMATELY 3 MINUTES INTO THE ABLATION PHASE, A FLUID LOSS OCCURRED AND FLUID LEAKED INTO THE VAGINAL CANAL. THE PHYSICIAN REPORTED THE PATIENT PREVIOUSLY HAD A CERVICAL PREGNANCY AND BIRTH 15-20 YEARS PRIOR, AT WHICH POINT A PORTION OF HER CERVIX HAD BEEN SURGICALLY REMOVED. POST PROCEDURE, THE PHYSICIAN PROPHYLACTICALLY APPLIED SILVADENE CREAM AS A PRECAUTIONARY MEASURE. THE DOCTOR SPOKE WITH THE PATIENT 3 DAYS AFTER THE PROCEDURE, WHO STATED THERE WAS NO EVIDENCE OF A BURN, SYMPTOMS, OR OTHER PROBLEMS ASSOCIATED WITH THE CERVICAL FLUID LEAK. THE PHYSICIAN DOES NOT PLAN TO DO ANY FOLLOW UP WITH THE PATIENT AS THERE IS NO ISSUE OR CONCERN FROM THIS EVENT.

    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 54 YR