BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 20384973 · Received October 7, 2024

    Report

    Report Number
    20384973
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    June 17, 2024
    Report Date
    July 3, 2024
    Manufacturer
    SILK ROAD MEDICAL, INC.
    Product Code
    NTE
    UDI-DI
    00811311020829
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SCRUB PULLED ARTERIAL SHEATH OUT OF PACKAGE, AND IT WAS NOTED THAT THE TIP WAS BENT AND LOOSE WHEN WIGGLED. SILK ROAD REPRESENTATIVE IN ROOM AND STATED THERE MAY BE SOMETHING WRONG WITH THE SHEATH AND NOT TO USE. ENTIRE SYSTEM PASSED OFF FIELD PRIOR TO PATIENT ENTERING ROOM. NEW SYSTEM OPENED AND USED. NOT SURE IF MANUFACTURER DEFECT OR USER ERROR WHEN REMOVING FROM SHEATH. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246767 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE SILK ROAD MEDICAL, INC. FG12522 305735 00811311020829

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female