BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOICE CRYOSPHERE CRYO-ABLATION PROBE

    MDR report key: 15331399 · Received August 31, 2022

    Report

    Report Number
    3011706110-2022-00030
    Event Type
    Injury
    Date Received
    August 31, 2022
    Date of Event
    August 4, 2022
    Report Date
    August 31, 2022
    Manufacturer
    ATRICURE, INC.
    Product Code
    GXH
    UDI-DI
    30840143902912
    PMA / PMN Number
    K180138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) THE CRYOS DEVICE WAS RETURNED FOR EVALUATION AND VISUALLY AND FUNCTIONALLY TESTED. THE COMPLAINT COULD NOT BE CONFIRMED AS CRYOS DEVICE MET OPERATING SPECIFICATIONS.

    Description of Event or Problem · 0

    ON (B)(6) 2022 THAT A MALE PATIENT UNDERWENT AN OFF-PUMP, NUSS / CRYO-NERVE BLOCK (CNB) PROCEDURE. DURING THE CNB, THE PHYSICIAN NOTICED AN AREA OF FROSTBITE ON THE PATIENT'S SKIN. THE IMPACTED SKIN WAS EXCISED. POST PROCEDURE, PATIENT WAS DOING WELL. 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
    2069820 CRYOICE CRYOSPHERE CRYO-ABLATION PROBE CRYOICE CRYOSPHERE CRYO-ABLATION PROBE GXH ATRICURE, INC. CRYOS 116705 30840143902912

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention