BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESYS HTA PROCERVA®

    MDR report key: 4925875 · Received July 20, 2015

    Report

    Report Number
    3005099803-2015-01985
    Event Type
    Injury
    Date Received
    July 20, 2015
    Date of Event
    June 19, 2015
    Report Date
    June 23, 2015
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT AGE OF THE PATIENT IS UNKNOWN, HOWEVER, IT WAS REPORTED THE PATIENT WAS OVER 18 YEARS. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GENESYS HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED IN A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2015 UNDER GENERAL ANESTHESIA. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS NOTED TO HAVE A LARGE UTERINE CAVITY AND A PATULOUS CERVIX. APPROXIMATELY SEVEN TO EIGHT MINUTES INTO THE ABLATION PHASE OF THE PROCEDURE, FLUID WAS NOTICED DRIPPING FROM THE TWO TUBING THAT CONNECTS TO THE SHEATH. AT THIS POINT, THE PHYSICIAN DECIDED TO ABORT PROCEDURE AND FELT THAT THE PATIENT RECEIVED A COMPLETE ABLATION. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE". ON (B)(6) 2015, THE FOLLOWING DAY, THE PATIENT REPORTED SOME BURNING AROUND THE ANUS AREA. THE PATIENT WAS ADVISED TO TREAT THE AREA WITH SILVADENE CREAM. 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
    468890 GENESYS HTA PROCERVA® DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - SPENCER M006580210 18005730

    Patients

    Seq Age Sex Outcome Treatment
    1 Other