BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 17040573 · Received June 1, 2023

    Report

    Report Number
    3012018285-2023-00001
    Event Type
    Injury
    Date Received
    June 1, 2023
    Date of Event
    May 5, 2023
    Report Date
    August 11, 2023
    Manufacturer
    CHANNEL MEDSYSTEMS, INC.
    Product Code
    MNB
    UDI-DI
    00850008595035
    PMA / PMN Number
    P180032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION AND WAS INTACT, APART FROM THE DETACHED LINER (WHICH WAS RETURNED IN A SEPARATE CONTAINER). THE LOT HISTORY RECORD REVIEW FOUND NO OBSERVATIONS RELATED TO THIS EVENT. THE DEVICE LOG DATA WAS DOWNLOADED AND ANALYZED. LINER DETACHMENT WAS DETERMINED TO BE DUE TO REMOVAL OF THE DEVICE WHEN THE LINER HAD NOT FULLY THAWED IN THE UTERINE CAVITY.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION IS IN PROGRESS AND HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    PATIENT HAD TREATMENT WITH THE CERENE CRYOTHERAPY DEVICE ON (B)(6) 2023 AND THE PHYSICIAN REPORTED THE PROCEDURE WAS UNEVENTFUL UNTIL DEVICE REMOVAL. THE PATIENT'S UTERUS WAS IN A NORMAL POSITION AND THE CAVITY SIZE WAS 7.2 CM. AT THE TIME OF REMOVAL, THE DEVICE WAS NOT FORTHCOMING AND COULD NOT BE REMOVED. THE PHYSICIAN HAD THE PATIENT COUGH TWICE TO PROVIDE DOWNWARD CONTRACTION TO HELP EXPEL THE DEVICE AND DISTRACT THE PATIENT, BUT IN THIS CASE, IT WAS NOT SUCCESSFUL. THE PHYSICIAN THEN APPLIED RING FORCEPS TO THE PROXIMAL END OF THE DEVICE (AT THE END OF THE SHEATH AND START OF PROBE) AT THE CERVIX, THEN HAD THE PATIENT BEAR DOWN, AT WHICH POINT WITH STEADY FIRM TENSION SHE SAW WHAT SHE BELIEVED TO BE THE SHEATH AND LINER COMING OUT OF THE CERVIX. UPON CLOSER LOOK IT WAS THE EXPOSED PROBE OF THE DEVICE WITH NO LINER. SHE CONTINUED TO PULL WITH STEADY AND FIRM TENSION AND THE DEVICE WAS REMOVED. UPON INSPECTING THE DEVICE, THE LINER HAD DETACHED AT THE LINER TETHER (DISTAL END OF THE DEVICE), WITH ONLY A SMALL PORTION VISIBLE AND ATTACHED TO THE TETHER. THE PHYSICIAN WAITED 15 MINUTES FOR A MORE COMPLETE THAW OF THE UTERINE CAVITY AND TRIED TO REMOVE THE LINER WITH FORCEPS UNDER ULTRASOUND GUIDANCE BUT WAS UNSUCCESSFUL. THE PHYSICIAN DID NOT HAVE HYSTEROSCOPY EQUIPMENT ON-SITE, THEREFORE IT WAS DECIDED SHE WOULD BRING THE PATIENT BACK TO REMOVE THE LINER UNDER HYSTEROSCOPIC GUIDANCE. THERE WAS NO INDICATION OF UTERINE PERFORATION AND THE PATIENT RECEIVED A COMPLETE CRYOABLATION TREATMENT. THE PHYSICIAN CONFIRMED BY ULTRASOUND THAT THE LINER WAS INSIDE THE UTERINE CAVITY. THE PATIENT WAS GIVEN ANTIBIOTICS AND DISCHARGED HOME ON HER OWN. SHE WAS TOLD TO MONITOR FOR LINER EXPULSION AND ANY SIGNS OF INFECTION. THE PHYSICIAN REPORTED THAT SHE PERFORMED HYSTEROSCOPY ON THE PATIENT IN THE OPERATING ROOM SETTING 5 DAYS LATER. ONCE IN THE UTERINE CAVITY, THE CERENE LINER WAS VISUALIZED TO BE "BALLED UP" AT THE FUNDUS. THE PHYSICIAN SUSPECTED THAT IN HER PREVIOUS ATTEMPT TO REMOVE THE LINER WITH FORCEPS UNDER ULTRASOUND GUIDANCE, SHE MAY HAVE PUSHED THE LINER UP INTO THE FUNDUS. THE LINER WAS INTACT AND WAS EASILY REMOVED. THE PHYSICIAN REPORTS THAT THE PATIENT IS DOING WELL POST-OP. THE CERENE DEVICE AND LINER WERE RETURNED FOR EVALUATION TO CHANNEL MEDSYSTEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017954 CERENE CRYOTHERAPY DEVICE ENDOMETRIAL ABLATION DEVICE MNB CHANNEL MEDSYSTEMS, INC. FGS-7000 100531447 00850008595035

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention