BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINEL CEREBRAL PROTECTION SYSTEM (US)

    MDR report key: 10401427 · Received August 13, 2020

    Report

    Report Number
    2134265-2020-10730
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Date of Event
    July 1, 2020
    Report Date
    August 13, 2020
    Manufacturer
    CLARET MEDICAL, INC.
    Product Code
    PUM
    UDI-DI
    00863229000004
    PMA / PMN Number
    DEN160043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DATE WAS NOT REPORTED. THE FIRST DAY OF THE MONTH OF THE AWARE DATE WAS USED AS AN ESTIMATE. DEVICE EVALUATED BY MANUFACTURER: THE SENTINEL SYSTEM WAS RETURNED WITH A UNKNOWN GUIDEWIRE. THE PROXIMAL FILTER OF THE SENTINEL WAS RETURNED UN-SHEATHED; THE DISTAL FILTER WAS RETURNED UN-SHEATHED AND INVERTED WITH THE STRUT TUBE BROKEN. THE ARTICULATING DISTAL SHEATH (ADS) WAS RELAXED AND THE INNER MEMBER WAS RETURNED WITHOUT VISIBLE DAMAGES UNDER THE REAR HANDLE SHELLS. FUNCTIONAL TESTING WAS CONDUCTED NOTED FLUSHING WAS ACHIEVED THROUGH ALL 3 FLUSH PORTS (REAR HANDLE, FRONT HANDLE AND DISTAL FILTER SLIDER). A TEST GUIDEWIRE WAS FULLY INSERTED, THE PROXIMAL FILTER UN-SHEATHED/ SHEATHED USING THE PROXIMAL FILTER SLIDER. THE ADS RESPONDED AS EXPECTED WHEN TURNING THE ARTICULATING KNOB. THE DISTAL FILTER SLIDER WAS PULLED AND NO FRICTION WAS FELT; HOWEVER, SHEATHING OF THE DISTAL FILTER WAS STOPPED DUE TO STRUT TUBE DAMAGE.

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON 30-JUL-2020. SENTINEL CEREBRAL PROTECTION SYSTEM WAS RETURNED WITH NO REPORTED ALLEGATION. UPON ANALYSIS, A DISTAL FILTER BREAK WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866945 SENTINEL CEREBRAL PROTECTION SYSTEM (US) EMBOLIC PROTECTION DEVICE PUM CLARET MEDICAL, INC. CMS15-10C-US 0025474436 00863229000004

    Patients

    Seq Age Sex Outcome Treatment
    1