BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOICE CRYOSPHERE MAX CRYOABLATION PROBE

    MDR report key: 23872177 · Received December 22, 2025

    Report

    Report Number
    3011706110-2025-00043
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    December 1, 2025
    Report Date
    December 22, 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 A CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE WITH STERNAL CRYO NERVE BLOCK THERAPY USING A CRYOSMAX DEVICE. DURING THE OPERATION, THE LEFT LUNG WAS INADVERTENTLY FROZEN BY A SURGICAL ASSISTANT. AFTER CLOSURE AND TRANSFER TO THE ICU, THE PATIENT REMAINED STABLE FOR A DAY BEFORE BEING RETURNED TO THE OR TO INVESTIGATE POSTOPERATIVE BLEEDING. A CIRCULAR INJURY WAS IDENTIFIED ON THE LEFT LUNG AND REPAIRED WITH SUTURES. DESPITE THIS, THE PATIENT DEVELOPED A PERSISTENT AIR LEAK, RESULTING IN BILATERAL LUNG COLLAPSE AND THE PLACEMENT OF PIGTAIL CATHETERS FOR DRAINAGE. 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
    1564067 CRYOICE CRYOSPHERE MAX CRYOABLATION PROBE DEVICE, SURGICAL, CRYOGENIC GXH ATRICURE, INC. CRYOSMAX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R