BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOICE CRYOSPHERE MAX CRYOABLATION PROBE

    MDR report key: 23877044 · Received December 23, 2025

    Report

    Report Number
    3011706110-2025-00045
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    December 1, 2025
    Report Date
    December 23, 2025
    Manufacturer
    ATRICURE, INC.
    Product Code
    GXH
    PMA / PMN Number
    K233170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, AND A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE CONDUCTED AS THE LOT NUMBER FOR THE DEVICE WAS NOT REPORTED OR ABLE TO BE ASCERTAINED.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY WITH CONCOMITANT STERNAL CRYO NERVE BLOCK THERAPY USING A CRYOSMAX DEVICE. DURING THE CONCOMITANT PROCEDURE, THE LEFT LUNG WAS INADVERTENTLY FROZEN. THE PROCEDURE WAS COMPLETED, AND WHILE THE PATIENT REMAINED STABLE INITIALLY, THEY WERE RETURNED TO OR AFTER FIRST POST OPERATIVE DAY FOR INVESTIGATION OF BLEEDING. A CIRCULAR INJURY WAS IDENTIFIED ON THE LEFT LUNG AND REPAIRED WITH SUTURES. THE PATIENT SUBSEQUENTLY DEVELOPED A PERSISTENT AIR LEAK, RESULTING IN BILATERAL LUNG COLLAPSE REQUIRING PLACEMENT OF DRAINAGE CATHETERS.THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919577 CRYOICE CRYOSPHERE MAX CRYOABLATION PROBE DEVICE, SURGICAL, CRYOGENIC GXH ATRICURE, INC. CRYOSMAX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O