BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOICE CRYO-ABLATION PROBE

    MDR report key: 7943496 · Received October 8, 2018

    Report

    Report Number
    3011706110-2018-00212
    Event Type
    Injury
    Date Received
    October 8, 2018
    Date of Event
    April 15, 2018
    Report Date
    October 8, 2018
    Manufacturer
    ATRICURE, INC.
    Product Code
    GXH
    PMA / PMN Number
    K180138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CASE (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION 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. THE COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2018 A (B)(6) FEMALE PATIENT UNDERWENT AN ATRIAL SEPTAL DEFECT REPAIR (ASD) AND WAS ENROLLED INTO THE (B)(6) CLINICAL STUDY. THE INTERCOSTAL CRYOANALGESIA PROCEDURE WAS PERFORMED PER PROTOCOL. THE PATIENT COMPLAINED OF HYPERESTHESIA THAT BEGAN ON (B)(6) 2018. DURING THE 90-DAY POST PROCEDURE FOLLOW-UP VISIT IT WAS DETERMINED THAT THE PATIENT DID NOT REQUIRE AN IN-OFFICE PAIN SENSITIVITY ASSESSMENT. AT THE 180 DAYS FOLLOW UP VISIT ON (B)(6) 2018, THE PATIENT STILL COMPLAINED ABOUT HAVING PAIN SENSITIVITY IN THE AREA AROUND THE SURGICAL INCISION SITE. THIS EVENT IS A PROCEDURE RELATED COMPLICATION. THERE WAS NO REPORTED DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782890 CRYOICE CRYO-ABLATION PROBE CRYOICE CRYO-ABLATION PROBE GXH ATRICURE, INC. CRYO2 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Disability