BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1032355 · Received April 22, 2008

    Report

    Report Number
    3005099803-2008-00369
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; AS IT WAS DISPOSED OF AND THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE. WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. TWO POSSIBLE LOTS HAVE BEEN IDENTIFIED FOR THE DEVICE: 33978 AND 34337. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THESE LOTS; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE FOR SIMILAR COMPLAINTS WAS CONDUCTED; NO ADDITIONAL SIMILAR COMPLAINTS HAVE BEEN RECORDED FOR THESE LOTS.THE HTA'S USER MANUAL AND THE DIRECTION FOR USE (DFU) STATES THAT THE CERVICAL SEAL MUST BE MAINTAINED AND OBSERVED FOR THE DURATION OF THE PROCEDURE IN ORDER TO REDUCE THE POSSIBILITY OF THERMAL INJURIES. IT ALSO REFERENCES BURNS AS A POTENTIAL ADVERSE EVENT WHICH CAN RESULT FROM HTA AS WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PATIENT UNDERWENT A THERAPEUTIC HYDROTHERMAL ABLATION (HTA) PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN PERFORMED A DIAGNOSTIC HYSTEROSCOPY WITH HTA SYSTEM. THE HTA DEVICE WAS REMOVED AND THE PHYSICIAN WENT IN AND DID A POLYPECTOMY AND A D&C. THE PHYSICIAN PLACED THE SCOPE BACK IN THE PATIENT AND COMPLETED ABLATION. WHEN THE PHYSICIAN REMOVED THE 4X4 SPONGE FROM THE VAGINA, THE SPONGE WAS SOAKING WET AND THE PATIENT SUFFERED A BURN FROM THE APEX TO INTROITUS REGION. THE BURN WAS CATEGORIZED AS A 2ND DEGREE BURN AND TREATED WITH SILVADENE CREAM. THE PHYSICIAN ALSO PRESCRIBED SILVADENE CREAM POST PROCEDURE. UPON FOLLOW UP WITH THE SITE, THE OR MANAGER INDICATED THAT THE PATIENT WAS SENT TO A WOUND CLINIC FOR FURTHER ANALYSIS (TREATMENT UNKNOWN) AND WAS RELEASED THE SAME DAY.

    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 UNK Required Intervention