BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESYS HTA PROCERVA®

    MDR report key: 3932879 · Received July 14, 2014

    Report

    Report Number
    3005099803-2014-02472
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    April 21, 2014
    Report Date
    June 18, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT USED PAST EXPIRY DATE. (B)(6). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF 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 UNDER GENERAL ANESTHESIA ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, AT APPROXIMATELY 8 TO 9 MINUTES INTO ABLATION, A THIRD FLUID LOSS DETECTED ALARM OCCURRED AND A SUBSEQUENT VAGINAL LEAK OF MORE THAN 10CC WAS OBSERVED. SKIN SLOUGHING WAS NOTED ON THE VAGINA AND CERVIX, AND WAS TREATED WITH SILVADENE CREAM. ON (B)(6) 2014, THE PATIENT REPORTED SOME PERINEAL DISCOMFORT. THE FOLLOWING DAY, PHYSICAL EXAMINATION CONFIRMED THE PRESENCE OF FIRST DEGREE BURN ON THE PERINEUM AND SECOND DEGREE BURNS ON THE CERVIX AND VAGINA. SILVADENE CREAM AND PAIN MEDICATION WERE PRESCRIBED. A WEEK AFTER, THE PATIENT WAS REPORTED TO BE RECOVERING WELL WITH NO FURTHER COMPLICATIONS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410613 GENESYS HTA PROCERVA® DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - SPENCER M006580211

    Patients

    Seq Age Sex Outcome Treatment
    1 Other