BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1222067 · Received November 6, 2008

    Report

    Report Number
    3005099803-2008-06092
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE SUSPECT DEVICE IS UNKNOWN; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES CAN NOT BE DETERMINED. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    WEIGHT IS UNKNOWN. DURING HYDRO THERMABLATOR (HTA) PROCEDURE, PHYSICIAN PERFORMED A MILD MYOMECTOMY LAPAROSCOPICALLY. THE PHYSICIAN RECOGNIZED THAT THE UTERUS WAS INTACT. THE PHYSICIAN STARTED THE HYSTEROSCOPY AND NOTICED 2 SMALL FIBROIDS SUBMUCOSAL 1 TO 2 CENTIMETERS IN SIZE. DURING THE HEATING PROCESS 2 FLUID LOSS ALARMS AT 10CC'S WERE RECEIVED. THE CASE WAS ABORTED. THE PHYSICIAN THEN PERFORMED A POLYPECTOMY AND PERFORATED THE UTERUS. THE PHYSICIAN CLOSED THE PERFORATION AND STOPPED THE BLEEDING FROM THE UTERUS. DURING HYSTEROSCOPY PHASE, THERE WAS NO PERFORATION NOTED. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROTHERMABLATOR PROCEDURE SET MNB BOSTON SCIENTIFIC CORPORATION M006560201 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention