BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 17466045 · Received August 4, 2023

    Report

    Report Number
    3012018285-2023-00002
    Event Type
    Injury
    Date Received
    August 4, 2023
    Date of Event
    December 14, 2021
    Report Date
    August 4, 2023
    Manufacturer
    CHANNEL MEDSYSTEMS, INC.
    Product Code
    MNB
    UDI-DI
    00850008595035
    PMA / PMN Number
    P180032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION WAS NOT POSSIBLE AS THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 0

    PRIOR TO INITIATION OF TREATMENT WITH THE CERENE CRYOTHERAPY DEVICE, "POSSIBLE PERFORATION" WAS DISPLAYED. THE PHYSICIAN REMOVED THE CERENE DEVICE AND CONFIRMED THE PRESENCE OF A UTERINE PERFORATION USING HYSTEROSCOPY; HE COMMENTED THAT IT WAS DIFFICULT TO MAINTAIN DISTENTION PRESSURE DURING HYSTEROSCOPY, WHICH WAS INDICATIVE OF THE PRESENCE OF A PERFORATION. THE PERFORATION WAS LOCATED MID-FUNDUS. THE PATIENT DID NOT RECEIVE AN ENDOMETRIAL ABLATION AND WAS OBSERVED FOR 1 HOUR, WITH NO SYMPTOMS ASSOCIATED WITH UTERINE PERFORATION (I.E., ABDOMINAL PAIN, DIZZINESS, AND NAUSEA) SEEN PRIOR TO PATIENT DISCHARGE. THE PHYSICIAN ADVISED THE PATIENT TO DELAY THE ENDOMETRIAL ABLATION PROCEDURE 3 TO 4 MONTHS WHILE THE PERFORATION NATURALLY HEALED. IN A FOLLOW-UP CONVERSATION BY PHONE WITH THE PHYSICIAN, HE COMMENTED THAT THE PATIENT'S UTERUS WAS MARKEDLY RETROVERTED AND DIFFICULT TO DILATE, AND THAT THE PERFORATION LIKELY HAPPENED WHEN HE WAS DILATING THE PATIENT, AS HE FELT THE DILATOR "JUMP" AS HE WAS INSERTING IT. THE PATIENT WAS 9 MONTHS POST-PARTUM (DELIVERED ON (B)(6) 2021) AND WAS NOT BREASTFEEDING AT THE TIME OF THE PROCEDURE. THE PATIENT RETURNED IN (B)(6) 2022 AND WAS SUCCESSFULLY TREATED WITH THE CERENE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995706 CERENE CRYOTHERAPY DEVICE ENDOMETRIAL ABLATION DEVICE MNB CHANNEL MEDSYSTEMS, INC. FGS-7000 85671346 00850008595035

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other CERVICAL DILATOR (MANUFACTURER UNKNOWN)