BEUDAMED
    FDA Adverse Event Other Summary report: N

    HYDROTHERMAL ABLATION

    MDR report key: 555870 · Received November 17, 2004

    Report

    Report Number
    MW1033448
    Event Type
    Other
    Date Received
    November 17, 2004
    Date of Event
    September 13, 2004
    Report Date
    November 17, 2004
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT HTA-HYDROABLATION FOR EXCESSIVE UTERINE BLEEDING. THEY HAD APPROPRIATE WORKUP-ULTRASOUND AND ENDOMETRIAL BIOPSY. IN AN EFFORT TO REDUCE BLEEDING WITHOUT RESORTING TO HYSTERECTOMY THEY WERE OFFERED THE HTA PROCEDURE. THE SALES REP, VERY NICE, HAD GIVEN ALL THE GLOSSY BROCHURE INFO. AND SAID THAT THERE WERE REALLY NO SIGNIFICANT PROBLEMS. THE SALES REP HAD MENTIONED THAT A FEW PTS HAD RECEIVED MINOR VAGINAL BURNS BUT THESE WERE DUE TO PHYSICIAN ERROR SUCH AS PULLING OUT THE ABLATOR DEVICE BEFORE THE COOLING CYCLE WAS COMPLETE, OR DUE TO PT "BUCKING" UNDER ANESTHESIA, WHICH CAUSED THE DEVICE TO SLIP OUT. ALL STEPS WERE TAKEN AS PER MANUFACTURER'S GUIDELINES AND THE COOL WATER TEST WAS PASSED. AT ALL TIMES THE OSTIA OF THE FALLOPIAN TUBES WERE VISUALIZED. FOUR MINUTES INTO THE HOT WATER CYCLE WHILE THE OSTIA STILL VISIBLE THE UTERUS HAD A CONTRACTION AND EXPELLED THE SCALDING WATER INTO THE VAGINA--IT RAN DOWN BEHIND THE SPECULUM AND THE PT ENDED UP WITH SECOND DEGREE BURNS TO THE SIDE AND BOTTOM OF THEIR VAGINA AND ALSO TO THEIR PERINEUM. THE PROCEDURE WAS ABANDONED. AN ATTEMPT WAS MADE TO USE A THERMACHOICE BALLOON ABLATION TO AT LEAST COMPLETE AN ABLATION BUT PHYSICIAN WAS UNABLE TO DO SO AS THE UTERUS HAD STRONG CONTRACTIONS THAT WOULD NOT ALLOW THE CYCLE TO START. A MIRENA IUCD WAS PLACED. PT WAS TREATED WITH SILVADENE AND IT WAS NOT IMMEDIATLEY APPARENT HOW BAD THE BURN WAS. WHEN SEEN A FEW DAYS LATER IT WAS AN OBVIOUS SECOND DEGREE WITH A LARGE BLISTER FORMATION IN THE VAGINA AND ON THE PERINEUM. PT REQUIRED NARCOTICS AND LOCAL LIDOCAINE TO EVEN MAKE IT THROUGH THE DAY. PT HAS STILL NOT BEEN ABLE TO HAVE INTERCOURSE. PT NO LONGER REQUIRES MEDICATION FOR PAIN DURING THE DAY. THE COMPANY HAS NOT RETURNED PHYSICIAN'S PHONE CALLS. THE PT CONTINUES TO BE NON-LITAGINOUS BUT VERY DISAPPOINTED THAT THEIR CONCERNS HAVE NOT BEEN ADDRESSED BY THE COMPANY. PHYSICIAN HAS CONTINUED TO OFFER WHAT SUPPORT THEY CAN AND FEEL THEY STILL HAVE A GOOD RELATIONSHIP. PHYSICIAN HAS ASKED IF THE EVENT HAS BEEN REPORTED BUT DOES NOT BELIEVE THAT IT HAS. PHYSICIAN HAS PT'S PERMISSION TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROTHERMAL ABLATION HTA MNB BOSTON SCIENTIFIC UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other