BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 2142682 · Received June 28, 2011

    Report

    Report Number
    3005099803-2011-02100
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL FOLLOW UP INFORMATION RECEIVED (B)(6) 2011. THE PHYSICIAN REPORTED THE CONDITION OF THE PATIENT AS OF A FOLLOW UP VISIT DATED (B)(6) 2011. THE PHYSICIAN REPORTED THAT THE BURN IS NOW VISIBLE AS A LIGHT, SMALLER AREA WHICH IS IN THE HEALING PROCESS, AND LESS DISCHARGE WAS ALSO NOTED. THE PATIENT CONDITION IS "FINE." A DHR REVIEW WAS CONDUCTED. NO EVIDENCE OF A MANUFACTURING RELATED POTENTIAL CAUSE FOR THIS TYPE OF EVENT WAS FOUND. THE DEVICE HAS NOT BEEN RETURNED TO DATE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, EXPIRATION AND MANUFACTURING DATES CANNOT BE DETERMINED. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT HAS BEEN DISPOSED OF AND THE DEVICE WILL NOT BE RETURNED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THIS EVENT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED DURING A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, TWO FLUID LOSS ALARM MESSAGES OCCURRED DURING THE HTA PROCEDURE. THE PHYSICIAN COMPLETED THE PROCEDURE. UPON REMOVAL OF THE SHEATH AND GAUZE, THE PHYSICIAN NOTICED A BURN ON THE POSTERIOR VAGINAL WALL OF THE CERVIX. THE BURN WAS NOT CLASSIFIED AND REPORTED THE AREA AS "WHITISH" IN APPEARANCE. NO TREATMENT WAS ADMINISTERED TO THE BURN. FOLLOW UP FROM THE PHYSICIAN ON (B)(6) 2011 CONFIRMED A CERVICAL LEAK WAS NOTICED AFTER THE FLUID LOSS ERROR MESSAGES OCCURRED. THE PATIENT WAS NOT DILATED BEYOND 8 MM AND TWO TENACULUM STABILIZERS WERE USED DURING THE PROCEDURE. THE PATIENT HAD A PATULOUS CERVIX AND THREE PREVIOUS VAGINAL BIRTHS. THE PHYSICIAN NOTICED THE BURN UPON COMPLETION OF THE PROCEDURE AT THE 6 O'CLOCK TO 9 O'CLOCK POSITION OF THE CERVIX ONLY. THE BURN WAS 3-4 CM IN SIZE AND SECOND DEGREE IN SEVERITY. THE COLOR OF THE AFFECTED AREA WAS WHITE AND NO METHOD OF TREATMENT WAS ADMINISTERED. ADDITIONAL INFORMATION FROM THE PHYSICIAN (PROVIDED ON (B)(6) 2011) DURING A FOLLOW UP VISIT ON (B)(6) 2011, REPORTED THE PATIENT IS NO LONGER EXPERIENCING ANY PAIN. ALSO, THE PATIENT IS EXPERIENCING A WATERY, YELLOWISH DISCHARGE. FURTHER, FOLLOW UP FROM THE PHYSICIAN PROVIDED ON (B)(6) 2011, REPORTED NO CHANGES TO THE BURN. THE PHYSICIAN ALSO REPORTED THE PATIENT HAD A BACTERIAL VAGINOSIS INFECTION AT THE TIME OF THE FOLLOW UP APPOINTMENT (ON (B)(6) 2011). THE PATIENT DID NOT HAVE ANY PRE-EXISTING MEDICAL CONDITIONS. THERE WERE NO FURTHER COMPLICATIONS REPORTED WITH THIS EVENT AND THE CONDITION OF THE PATIENT IS REPORTED TO BE "STABLE."

    Description of Event or Problem · 1

    A HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED DURING A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, TWO FLUID LOSS ALARM MESSAGES OCCURRED DURING THE HTA PROCEDURE. THE PHYSICIAN COMPLETED THE PROCEDURE. UPON REMOVAL OF THE SHEATH AND GAUZE, THE PHYSICIAN NOTICED A BURN ON THE POSTERIOR VAGINAL WALL OF THE CERVIX. THE BURN WAS NOT CLASSIFIED AND REPORTED THE AREA AS "WHITISH" IN APPEARANCE. NO TREATMENT WAS ADMINISTERED TO THE BURN. FOLLOW UP FROM THE PHYSICIAN ON (B)(6), 2011 CONFIRMED A CERVICAL LEAK WAS NOTICED AFTER THE FLUID LOSS ERROR MESSAGES OCCURRED. THE PATIENT WAS NOT DILATED BEYOND 8 MM AND TWO TENACULUM STABILIZERS WERE USED DURING THE PROCEDURE. THE PATIENT HAD A PATULOUS CERVIX AND THREE PREVIOUS VAGINAL BIRTHS. THE PHYSICIAN NOTICED THE BURN UPON COMPLETION OF THE PROCEDURE AT THE 6 O'CLOCK TO 9 O'CLOCK POSITION OF THE CERVIX ONLY. THE BURN WAS 3-4 CM IN SIZE AND SECOND DEGREE IN SEVERITY. THE COLOR OF THE AFFECTED AREA WAS WHITE AND NO METHOD OF TREATMENT WAS ADMINISTERED. ADDITIONAL INFORMATION FROM THE PHYSICIAN (PROVIDED ON (B)(6), 2011) DURING A FOLLOW UP VISIT ON (B)(6), 2011, REPORTED THE PATIENT IS NO LONGER EXPERIENCING ANY PAIN. ALSO, THE PATIENT IS EXPERIENCING A WATERY, YELLOWISH DISCHARGE. FURTHER, FOLLOW UP FROM THE PHYSICIAN PROVIDED ON (B)(6), 2011, REPORTED NO CHANGES TO THE BURN. THE PHYSICIAN ALSO REPORTED THE PATIENT HAD A BACTERIAL VAGINOSIS INFECTION AT THE TIME OF THE FOLLOW UP APPOINTMENT (ON (B)(6), 2011). THE PATIENT DID NOT HAVE ANY PRE-EXISTING MEDICAL CONDITIONS. THERE WERE NO FURTHER COMPLICATIONS REPORTED WITH THIS EVENT AND THE CONDITION OF THE PATIENT IS REPORTED TO BE "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - MARLBOROUGH M006560211

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR