BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 20242207 · Received September 17, 2024

    Report

    Report Number
    3012018285-2024-00021
    Event Type
    Injury
    Date Received
    September 17, 2024
    Date of Event
    August 23, 2024
    Report Date
    November 5, 2024
    Manufacturer
    CHANNEL MEDSYSTEMS, INC.
    Product Code
    MNB
    UDI-DI
    00850008595035
    PMA / PMN Number
    P180032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE DETAILS IN THE COMPLAINT REPORT AND ANALYSIS OF THE RETURNED DEVICE, THE ROOT CAUSE OF THE "POSSIBLE PERFORATION" FAULT APPEARS TO HAVE BEEN THE DEVICE CORRECTLY DETECTING A UTERINE PERFORATION, WHICH IS A KNOWN COMPLICATION OF ENDOMETRIAL ABLATION.

    Additional Manufacturer Narrative · 0

    PHYSICIAN STATED THAT HE DID NOT BELIEVE THE PERFORATION WAS DEVICE-RELATED, AND THAT PERFORATION IS A KNOWN COMPLICATION OF ENDOMETRIAL ABLATION. A FOLLOW-UP REPORT WILL BE FILED WHEN THE DEVICE IS RETURNED AND THE INVESTIGATION CAN BE COMPLETED.

    Description of Event or Problem · 0

    A PATIENT WITH A UTERINE SOUND LENGTH OF 8.5 CM AND UTERINE CAVITY LENGTH OF 4.5 CM WAS TREATED WITH THE CERENE CRYOTHERAPY DEVICE. THE DEVICE WAS INSERTED INTO THE PATIENT, AFTER WHICH THE DOCTOR SET THE DEVICE TO THE CAVITY LENGTH AND CONFIRMED PLACEMENT OF THE DEVICE AT THE FUNDUS. AFTER ATTEMPTING TO INFLATE, THE DEVICE DISPLAYED "POSSIBLE PERFORATION." THE DEVICE WAS REMOVED, AND THE PHYSICIAN DECIDED TO USE A SECOND DEVICE WITH THE SAME LOT NUMBER. UPON INSERTION, THE PHYSICIAN NOTED THAT THE DEVICE PASSED FAR ENOUGH THAT THE SHEATH MARKING SHOWING AT THE EXTERNAL OS WAS 12 CM. THE PHYSICIAN REMOVED THE DEVICE AND PERFORMED HYSTEROSCOPY. CAVITY VISUALIZATION WAS NOT ACHIEVED, AS THE PHYSICIAN WAS UNABLE TO MAINTAIN FLUID PRESSURE, INDICATING A PERFORATION. THE PATIENT WAS KEPT FOR OBSERVATION FOR A FEW HOURS POST-PROCEDURE AND SENT HOME WITH ANTIBIOTICS EXPECTANTLY. FOLLOW-UP WITH THE PATIENT AT HOME SEVERAL HOURS LATER INDICATED THAT SHE WAS DOING FINE. THE PATIENT RETURNED TO THE OFFICE FOUR DAYS LATER AND WAS REPORTED TO BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1902133 CERENE CRYOTHERAPY DEVICE ENDOMETRIAL ABLATION DEVICE MNB CHANNEL MEDSYSTEMS, INC. FGS-7000 104808353 00850008595035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other