BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 2241223 · Received September 9, 2011

    Report

    Report Number
    3005099803-2011-02985
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS NOT KNOWN PER THE COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE, IT WAS DISPOSED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED IN A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2011 (PATIENT ID, AGE, AND WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, THE PATIENT RECEIVED A VAGINAL BURN 6 MINUTES INTO THE ABLATION. THE PHYSICIAN REPORTED, SHE WAS UNABLE TO OBTAIN A GOOD CERVICAL SEAL. THEREFORE, A TENACULM WAS USED TO ASSIST. ADDITIONALLY, A 4X4 AND A BLUE DRAPE WERE USED. THE PHYSICIAN REPORTED ADDING ANOTHER TENACULUM AFTER THE SECOND FLUID LOSS. ABLATION WAS STARTED AND ANOTHER 10CC FLUID LOSS OCCURRED. THE PHYSICIAN STOPPED THE PROCEDURE AND COOLED DOWN THE MACHINE. THE PROCEDURE WAS THEN RESTARTED USING THE SAME PROCEDURE SET. SIX MINUTES INTO THE ABLATION WATER WAS NOTED ON THE BLUE TOWEL. IT WAS REPORTED THAT THE PATIENT THEN MOVED BECAUSE, SHE FELT A BURN. 4 WEEKS POST OPERATIVELY, THE PATIENT IS BEING TREATED FOR THE BURN. AN ADDITIONAL ATTEMPT HAS BEEN MADE TO OBTAIN FOLLOW UP EVENT DETAILS WITH NO RESPONSE FROM THE CLINICIAN.

    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 Other