BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1150512 · Received September 5, 2008

    Report

    Report Number
    3005099803-2008-04404
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE SUSPECT DEVICE IS UNKNOWN; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES WERE UNK. THE COMPLAINT 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 THAT DURING AN IN-OFFICE ABLATION, USING THE HYDRO THERMABLATOR PROCEDURE SET TO TREAT A PATIENT WITH A BICORNUATE UTERUS, THE PATIENT WAS OBSERVED TO HAVE VAGINAL BURNS. PRIOR TO THE PROCEDURE THE PATIENT WAS MEDICATED BUT ALERT VIA CONSCIOUS SEDATION. THE PHYSICIAN PERFORMED A NORMAL HYSTEROSCOPY AND PLACED THE SCOPE AT INTERNAL OS AND BEGAN THE PROCEDURE. ABOUT 3 MINUTES INTO THE CASE, THE PHYSICIAN TRIED TO GET BETTER CIRCULATION. THE PHYSICIAN REMOVED THE TENNACULAM/STABILIZER AND MOVED THE SCOPE INTO THE LEFT SIDE OF THE CORNUATE BUT WAS NOT ABLE TO GET GOOD VISUALIZATION. THE PHYSICIAN THEN MOVED THE SCOPE THE RIGHT CORNUATE, HELD IT FOR APPROXIMATELY 30 SECONDS THEN BACKED THE SCOPE OUT CAUSING A LEAK AROUND THE SCOPE. AT APPROXIMATELY 3 1/2 MINS INTO PROCEDURE THERE WAS FLUID LOSS ALARMS (THE FLUID LOSS PER MINUTE IS UNKNOWN). THE PATIENT BUCKED (JUMPED) WHEN THE HOT FLUID IN THE VAGINA WAS FELT CAUSING THE SCOPE TO COME COMPLETELY OUT. HOT SALINE FILLED THE PATIENTS VAGINA, THE PATIENT SCREAMED. THE PHYSICIAN PULLED THE SCOPE AWAY AND THE NURSE HIT THE STOP BUTTON. THE PHYSICIAN DOUSED THE VAGINA WITH STERILE WATER TO COOL OFF THE SALINE. UPON EXAMINATION, THE PHYSICIAN OBSERVED "WHITENESS" AT VAGINAL APEX ABOVE THE HYMAN RING, ON THE WALL OF THE VAGINA (THE PHYSICIAN WAS UNABLE TO CLASSIFY THE BURN). NO EXTERNAL BURNS TO PERINEUM OR ANUS WERE NOTED. THE PATIENT WAS IN EXTREME PAIN DUE TO THE VAGINAL BURN AND WAS SENT HOME WITH TORADOL, LLYDOCAINE JELLY, AND SYLVADINE CREAM. THE PHYSICIAN HAS FOLLOWED THE PATIENT AND REPORTED TO THE MANUFACTURER REPRESENTATIVE THAT PATIENT IS DOING FINE AND PLANNING ON RESCHEDULING ANOTHER ATTEMPT SOON.

    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 43 YR Other| R