BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1062963 · Received June 19, 2008

    Report

    Report Number
    3005099803-2008-00793
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE USED IS UNK, CONSEQUENTLY, THE MANUFACTURE AND EXPIRATION DATE OF THE DEVICE IS UNK. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; SINCE IT WAS DISPOSED OF A FAILURE ANALYSIS IS NOT AVAILABLE. WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP. THAT A PT UNDERWENT A THERAPEUTIC HYDROTHERMAL ABLATION (HTA) PROCEDURE THAT OCCURRED IN 2008. DURING THE PROCEDURE, APPROX. 3 1/2 MINUTES INTO THE ABLATION, A FLUID LOSS ALARM (RATE IS NOT KNOWN) OCCURRED. THE PHYSICIAN PAUSED THE PROCEDURE AND TIGHTENED THE TENACULUM AND MOVED THE SCOPE, INADVERTENTLY THE SCOPE CAME OUT OF THE CERVIX. THE PT SUFFERED A MODERATE BURN (DEGREE AND CHARACTERISTICS OF THE BURN ARE UNK). THE PHYSICIAN DECIDED TO CONTINUE THE PROCEDURE AND RE-POSITIONED THE SCOPE AND STARTED THE SYSTEM. REPORTEDLY, THE PHYSICIAN REMOVED THE SCOPE BEFORE COOL DOWN WAS COMPLETE. THE PHYSICIAN PACKED THE VAGINA WITH SILVADENE CREAM. ACCORDING TO THE COMPLAINANT, THE PT IS DOING FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other