BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINEL CEREBRAL PROTECTION SYSTEM (US)

    MDR report key: 10525251 · Received September 11, 2020

    Report

    Report Number
    2134265-2020-12517
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    July 1, 2020
    Report Date
    September 11, 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

    DATE OF EVENT: 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 UNIT WAS RETURNED WITH THE DISTAL FILTER SLIDER FULLY DETACHED. THE DISTAL FILTER WAS UN-SHEATHED, INVERTED AND THE STRUT TUBE WAS BROKEN. THE PROXIMAL FILTER WAS UN-SHEATHED AND THE ARTICULATING DISTAL SHEATH (ADS) WAS RELAXED. THE REAR HANDLE SHELLS AND DISTAL FILTER COUPLER WERE UNRAVELED AND THE TRI-LAYER WAS DETACHED. TESTING OF THE DEVICE NOTED THAT FLUSHING WAS ACHIEVED THROUGH FRONT HANDLE FLUSH PORT, HOWEVER, FLUSHING WAS NOT ACHIEVED THROUGH THE REAR HANDLE FLUSH PORT. FLUID WENT BACKWARDS DUE TO THE DETACHED COMPONENT. FLUSHING COULD NOT BE PERFORMED THROUGH DISTAL FILTER SLIDER. A TEST GUIDEWIRE WAS FULLY INSERTED AND THE ADS RESPONDED AS EXPECTED WHEN TURNING THE ARTICULATING KNOB. THE PROXIMAL FILTER SHEATHED AND UN-SHEATHED USING THE PROXIMAL FILTER SLIDER. THE DISTAL FILTER COULD NOT BE SHEATHED OR UN-SHEATHED DUE TO THE DISTAL FILTER SLIDER DETACHMENT. APPARENT ADHESIVE RESIDUES WERE VISIBLE IN THE DISTAL FILTER COUPLER AND MANUAL SHEATHING OF THE DISTAL FILTER WAS ATTEMPTED WITH GUIDEWIRE SUPPORT, BUT COULD NOT BE ACHIEVED.

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON 13-AUG-2020. THE SENTINEL CEREBRAL PROTECTION SYSTEM WAS RETURNED FOR ANALYSIS WITHOUT ANY PREVIOUSLY REPORTED INCIDENTS. ANALYSIS REVEALED THAT THE DEVICE APPEARED TO HAVE BEEN USED AND THE DISTAL FILTER STRUT TUBE WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989433 SENTINEL CEREBRAL PROTECTION SYSTEM (US) EMBOLIC PROTECTION DEVICE PUM CLARET MEDICAL, INC. CMS15-10C-US 0025474436 00863229000004

    Patients

    Seq Age Sex Outcome Treatment
    1