BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINEL CEREBRAL PROTECTION SYSTEM (US)

    MDR report key: 10379642 · Received August 7, 2020

    Report

    Report Number
    2134265-2020-10718
    Event Type
    Malfunction
    Date Received
    August 7, 2020
    Date of Event
    July 14, 2020
    Report Date
    August 7, 2020
    Manufacturer
    CLARET MEDICAL, INC.
    Product Code
    PUM
    UDI-DI
    00863229000004
    PMA / PMN Number
    DEN160043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INABILITY TO RESHEATH THE PROXIMAL FILTER OCCURRED. A SENTINEL CEREBRAL PROTECTION DEVICE WAS SUCCESSFULLY PLACED INSIDE THE PATIENT. UPON RETRIEVAL OF THE DEVICE, IT WAS NOTED THAT PROXIMAL FILTER SLIDER WOULD ONLY MOVE HALF OF TRAVEL DISTANCE. THE PROXIMAL FILTER WAS PARTIALLY CONSTRAINED. THE SENTINEL CATHETER WAS WITHDRAWN VIA THE SHEATH WITH THE PROXIMAL FILTER PARTIALLY DEPLOYED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842021 SENTINEL CEREBRAL PROTECTION SYSTEM (US) EMBOLIC PROTECTION DEVICE PUM CLARET MEDICAL, INC. CMS15-10C-US 0025119281 00863229000004

    Patients

    Seq Age Sex Outcome Treatment
    1