BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOICE CRYO-ABLATION PROBE

    MDR report key: 7944689 · Received October 8, 2018

    Report

    Report Number
    3011706110-2018-00213
    Event Type
    Injury
    Date Received
    October 8, 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
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (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 CRYO DEVICE WAS NOT REPORTED OR ABLE TO BE SUBSEQUENTLY ASCERTAINED.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT HE WAS HAVING AN ISSUE WITH A PATIENT HE USED CRYO DEVICE IN (B)(6) 2018, FOR A SURGICAL PROCEDURE FOR BROKEN RIBS WHERE HE HAD TO PLATE THE RIBS BACK TOGETHER. THE SURGEON RESECTED THE BOTTOM LIP OF THE RIB, EXPOSED THE NEUROVASCULAR BUNDLE AND FROZE LEVELS 7-10 NERVE EXTERNALLY, AT LEAST 6CM AWAY FROM THE TRANSVERSE PROCESS LATERALLY UNDER EACH RIB FOR PAIN MANAGEMENT. TWO MONTHS POST-PROCEDURE PATIENT HAS A BULGE POSTEROLATERAL, LOWER FLANK, CONSISTENT WITH LOWER THORACOABDOMINAL WALL DENERVATION. PATIENT IS UNDERGOING PHYSIOTHERAPY. THIS EVENT IS A PROCEDURE RELATED COMPLICATION. ATRICURE DOES NOT RECOMMEND ABLATION BELOW THE 9TH INTERCOSTAL SPACE PER CRYOANALGESIA PROCEDURAL GUIDE (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783870 CRYOICE CRYO-ABLATION PROBE CRYOICE CRYO-ABLATION PROBE GXH ATRICURE, INC. ATRICURE CRYO PEN (UNKNOWN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability