BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOICE CRYO-ABLATION PROBE

    MDR report key: 10445737 · Received August 24, 2020

    Report

    Report Number
    3011706110-2020-00026
    Event Type
    Injury
    Date Received
    August 24, 2020
    Report Date
    August 24, 2020
    Manufacturer
    ATRICURE, INC.
    Product Code
    GXH
    PMA / PMN Number
    K180138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CRYO2 DEVICE WAS NOT RETURNED FOR EVALUATION AS EVENT TOOK PLACE POST PROCEDURE, DEVICE HAD BEEN DISCARDED AND A DEVICE HISTORY REVIEW WAS UNABLE TO BE COMPLETED AS THE RELEVANT LOT NUMBER FOR THE CRYO2 DEVICE WAS NOT REPORTED OR ABLE TO BE SUBSEQUENTLY ASCERTAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED ON 29-JUL-2020 THAT IN (B)(6) 2020 A PATIENT UNDERWENT A BRONCHOSCOPY, RIGHT LOWER LOBE LOBECTOMY, AND NERVE BLOCK PROCEDURE. THE SURGEON MADE THORACOTOMY INCISION AT THE 5TH INTERCOSTAL SPACE FOR THE LOBECTOMY PROCEDURE AND USED CRYO 2 DEVICE TO ACHIEVE NERVE BLOCK. POST PROCEDURE ON A FOLLOW UP VISIT IT WAS NOTED THAT THE PATIENT HAD DROOPING EYE LID SIGNS OF HORNER¿S SYNDROME. THIS WAS A PROCEDURAL COMPLICATION. THERE WAS NO REPORTED DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910315 CRYOICE CRYO-ABLATION PROBE CRYOICE CRYO-ABLATION PROBE GXH ATRICURE, INC. CRYO2 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability