BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 1901221 · Received November 17, 2010

    Report

    Report Number
    3005099803-2010-04706
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 27, 2010
    Manufacturer
    NORTH AMERICAN STERILIZATION &
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE DEVICE WAS DISPOSED OF AND IS NOT AVAILABLE FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT 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) 2010. ACCORDING TO THE COMPLAINANT, AN ALARM WAS GENERATED FOR KINKED TUBING, HOWEVER, NO KINKS, PINCHES, OR OCCLUSIONS WERE OBSERVED. THE CASE WAS CONTINUED UNTIL 8 MINUTES INTO THE ABLATION, WHEN A FLUID LOSS ALARM OF 10 CC/MIN WAS GENERATED. THE PROCEDURE WAS ABORTED AT THAT TIME, AND A BURN WAS OBSERVED. THE BURN WAS BOTH INTERNAL AND EXTERNAL, INCLUDING FIRST AND SOME SECOND DEGREE BURNS ON THE CERVIX, VAGINA, LABIA, AND PERINIUM. THERE WAS NO INDICATION OF OVERDILATION, HOWEVER THE PATIENT HAS A "LARGE" POLYP WHICH ALMOST REACHES THE CERVICAL OS. THE ONLY ABNORMALITY THE PHYSICIAN NOTICED DURING THE PROCEDURE WAS THAT THE RETURN IN THE TUBING APPEARED DARK BROWN. THE SHEATH WAS NOT MOVED EXCESSIVELY DURING THE CASE, AND THE PATIENT DID NOT MOVE. ADDITIONALLY, THE HEIGHT OF THE IV POLE WAS VERIFIED, AND A TENACULUM STABILIZER AND SPECULUM WERE USED. THE PATIENT WAS TREATED WITH SILVADENE CREAM AND STAYED IN THE HOSPITAL OVERNIGHT. SHE WAS DISCHARGED THE FOLLOWING MORNING, AND WAS REPORTED TO BE "DOING WELL." NO GRAFTING WILL BE NECESSARY. 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 NORTH AMERICAN STERILIZATION & M006560211 0000039563

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention