BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1021325 · Received March 28, 2008

    Report

    Report Number
    3005099803-2008-00310
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    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.

    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. ACCORDING TO THE COMPLAINANT, THE PT HAD A PATULOUS CERVIX AND A GOOD SEAL WAS MAINTAINED WITH LITTLE DILATION NEEDED. IT IS UNK WHAT TYPE OR AMOUNT OF ANESTHESIA WAS ADMINISTERED TO THE PT. DURING THE PROCEDURE THE PT BUCKED (MOVED), CAUSING THE SHEATH TO MOVE AND TRIGGERING A FLUID LOSS ALARM (RATE UNK). THE PROCEDURE WAS ABORTED AND THE VAGINA WAS FILLED WITH COOL FLUID. A SEVERE VAGINAL BURN (DEGREE UNK) WAS NOTED. THE PT WAS ADMITTED TO THE HOSP FOR OVERNIGHT OBSERVATION THEN RELEASED. IT IS UNK WHAT FORM OF TREATMENT WAS GIVEN, IF ANY. ACCORDING TO THE PHYSICIAN, THE PT IS DOING FINE AND A FULL RECOVERY IS EXPECTED.

    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 Hospitalization