BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COR-KNOT®

    MDR report key: 20504888 · Received October 22, 2024

    Report

    Report Number
    20504888
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    May 2, 2024
    Report Date
    July 21, 2024
    Manufacturer
    LSI SOLUTIONS, INC.
    Product Code
    HCF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EVENT REPORT FOR A MEDICAL DEVICE MALFUNCTION OF COR-KNOT MIS COMBO KIT, REF # 031082, EXPIRATION DATE 10-31-2026. LOT # 2277966. THE CASE IS FOR A MINI THORACOTOMY AORTIC VALVE REPLACEMENT. AS PER THE SCRUB TECH, THE COR-KNOT CUT THE SUTURE WITHOUT IT BEING DEPLOYED. THEY WERE ON THE SECOND SUTURE WHEN IT HAPPENED. THEY HAVE TO REMOVE THE VALVE (IMPLANTED TISSUE) AND PUT IN NEW SUTURE, REPLACE A NEW INSPIRIS TISSUE VALVE IN. ORIGINAL PACKAGE AND DEVICE ARE STORED WITH THE BOX, IT WAS NOT COMPROMISED NOR DAMAGE PRIOR TO OPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2006335 COR-KNOT® INSTRUMENT, LIGATURE PASSING AND KNOT TYING HCF LSI SOLUTIONS, INC. 031082 2277966

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Male