BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM

    MDR report key: 16484928 · Received March 6, 2023

    Report

    Report Number
    16484928
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Date of Event
    January 30, 2023
    Report Date
    February 2, 2023
    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

    SURGEON ATTEMPTED TO USE THE ENROUTE TRANSCARTOID NEUROPROTECTION SYSTEM AND FOUND LEAKAGE FROM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708308 ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE SILK ROAD MEDICAL, INC. FG12522 0302868 00811311020829

    Patients

    Seq Age Sex Outcome Treatment
    1 25185 DA Male