BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOICE CRYOSPHERE CRYO-ABLATION PROBE

    MDR report key: 16147070 · Received January 12, 2023

    Report

    Report Number
    3011706110-2023-00002
    Event Type
    Injury
    Date Received
    January 12, 2023
    Date of Event
    December 13, 2022
    Report Date
    January 12, 2023
    Manufacturer
    ATRICURE, INC.
    Product Code
    GXH
    UDI-DI
    10840143902543
    PMA / PMN Number
    K182565
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CRYOS DEVICE WAS RETURNED FOR EVALUATION AND INVESTIGATION CONFIRMED THAT THE EXTERNAL PROBE SURFACE WAS AT OR BELOW 0 CELSIUS, WHICH COULD HAVE RESULTED IN THE REPORTED SKIN FREEZE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A PATIENT UNDERWENT A PECTUS REPAIR WITH CRYO NERVE BLOCK. TISSUE NEAR THE INCISION SITE CAME IN CONTACT WITH THE CRYOS PROBE AND DISCOLORED. SURGEON ELECTED TO EXCISE THIS TISSUE. THE PROCEDURE WAS COMPLETED, AND THERE WERE NO ADDITIONAL REPORTED COMPLICATIONS WITH THE PATIENT. 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
    573032 CRYOICE CRYOSPHERE CRYO-ABLATION PROBE CRYOICE CRYOSPHERE CRYO-ABLATION PROBE GXH ATRICURE, INC. CRYOS 123352 10840143902543

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention