BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 20374801 · Received October 4, 2024

    Report

    Report Number
    3012018285-2024-00022
    Event Type
    Injury
    Date Received
    October 4, 2024
    Date of Event
    August 23, 2024
    Report Date
    October 4, 2024
    Manufacturer
    CHANNEL MEDSYSTEMS, INC.
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE DISCARDED SO INVESTIGATION OF DEVICE COULD NOT BE COMPLETED.

    Description of Event or Problem · 0

    THE PHYSICIAN CONTACTED THE MANUFACTURER'S CLINICAL AFFAIRS REPRESENTATIVE TO DISCUSS A PATIENT ON WHOM SHE HAD PERFORMED ENDOMETRIAL ABLATION WITH THE CERENE CRYOTHERAPY DEVICE 12 DAYS PRIOR. THE PHYSICIAN REPORTED THAT THE PROCEDURE HAD GONE WELL, THE DEVICE HAD PERFORMED AS EXPECTED, AND THE PATIENT WAS SENT HOME FOLLOWING TREATMENT. PRE- AND POST-OP HYSTEROSCOPY REVEALED NO ABNORMALITIES OR EVIDENCE FOR TRAUMA OR PERFORATION. WITHIN A COUPLE OF HOURS OF THE PATIENT BEING HOME, SHE CALLED THE PHYSICIAN'S OFFICE COMPLAINING OF VERY HEAVY BLEEDING, SEVERE PAIN, AND CRAMPING. THE PATIENT RETURNED TO THE PHYSICIAN'S OFFICE TO BE EXAMINED, UPON WHICH IS WAS DISCOVERED THAT THE PATIENT HAD A CERVICAL LACERATION FROM THE TENACULUM. THIS WAS INITIALLY ASSOCIATED WITH SIGNIFICANT BLEEDING BUT ULTIMATELY RESOLVED WITHOUT ANY NEED TO SECURE HEMOSTASIS. SINCE THEN, THE PATIENT HAS CONTINUED TO EXPERIENCE HEAVY BLEEDING, SEVERE PAIN, AND CRAMPING DESPITE THE USE OF NSAIDS AND OXYCODONE FOR PAIN MANAGEMENT. THE PHYSICIAN WAS CONNECTED WITH THE MANUFACTURER'S MEDICAL ADVISOR, WHO SPOKE WITH THE PHYSICIAN ON (B)(6) 2024 AND CONCLUDED THAT THE TIMING OF HORMONAL SUPPRESSION WITH PROGESTIN PREOPERATIVELY FOLLOWED BY DISCONTINUATION IS THE MOST LIKELY REASON FOR THE ONGOING COMPLAINTS OF EXCESSIVE UTERINE BLEEDING AND CRAMPING AFTER AN OTHERWISE UNEVENTFUL ENDOMETRIAL ABLATION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726491 CERENE CRYOTHERAPY DEVICE ENDOMETRIAL ABLATION DEVICE MNB CHANNEL MEDSYSTEMS, INC. FGS-7000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention