BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOICE CRYOSPHERE CRYOABLATION PROBE

    MDR report key: 19919537 · Received August 6, 2024

    Report

    Report Number
    3011706110-2024-00049
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    July 14, 2024
    Report Date
    August 6, 2024
    Manufacturer
    ATRICURE, INC.
    Product Code
    GXH
    PMA / PMN Number
    K200697
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 VIDEO-ASSISTED THORACOSCOPIC APPROACH NUSS PROCEDURE WITH CONCOMITANT CRYO NERVE BLOCK, USING A CRYOS PROBE. DURING THE PROCEDURE, THE SURGEON CHOSE TO MAINTAIN CONTACT BETWEEN THE LUNG AND THE BRAIDED PORTION OF THE DEVICE. THE PROBE STUCK TO THE LUNG AND POSTOPERATIVELY THE PATIENT EXPERIENCED PNEUMOTHORAX. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED. 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
    1562771 CRYOICE CRYOSPHERE CRYOABLATION PROBE CRYOSURGICAL PROBE GXH ATRICURE, INC. CRYOS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male Other