BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 2190107 · Received August 4, 2011

    Report

    Report Number
    3005099803-2011-02530
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    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 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 GENESYS HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED DURING A HYDROTHERMABLATION (HTA) PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE HYSTEROSCOPY PHASE, THE PATIENT'S UTERUS WAS PERFORATED UPON INSERTION OF THE SHEATH. THE PROCEDURE WAS ABORTED. ADDITIONAL FOLLOW UP EVENT INFORMATION FROM THE PHYSICIAN CONFIRMED THE UTERINE PERFORATION OCCURRED UPON INSERTION OF THE HTA SHEATH. THE EVENT OCCURRED DURING THE HYSTEROSCOPY PHASE. THE PROCEDURE WAS IMMEDIATELY ABORTED AFTER THE UTERINE PERFORATION WAS NOTICED. THE SIZE OF THE PERFORATION WAS LESS THAN 1 CM. A LAPAROSCOPY WAS PERFORMED TO VISUALIZE THE PERFORATION. IN ADDITION, THE EDGE OF THE UTERINE PERFORATION WAS CAUTERIZED WITH A NEEDLE POINT CAUTERY DEVICE. THERE WERE NO FURTHER COMPLICATIONS REPORTED WITH THIS EVENT. THE CONDITION OF THE PATIENT IS REPORTED TO BE "STABLE."

    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 M006580211 0000041873

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention