BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINEL CEREBRAL PROTECTION SYSTEM (US)

    MDR report key: 10586760 · Received September 25, 2020

    Report

    Report Number
    2134265-2020-13210
    Event Type
    Malfunction
    Date Received
    September 25, 2020
    Date of Event
    August 1, 2020
    Report Date
    September 25, 2020
    Manufacturer
    CLARET MEDICAL, INC.
    Product Code
    PUM
    PMA / PMN Number
    DEN160043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: ESTIMATED. DEVICE EVALUATED BY MFR: THE UNIT WAS RETURNED IN A GENERIC PLASTIC BAG, OVERALL VISUAL REVISION DID NOT IDENTIFY FAILURES OR EVIDENCE THAT COULD BE LOST DUE TO DECONTAMINATION PROCESS. THE UNIT WAS RETURNED WITH A UNKNOWN GUIDEWIRE. THE PROXIMAL FILTER WAS RETURNED UN-SHEATHED. THE DISTAL FILTER WAS RETURNED UN-SHEATHED AND INVERTED WITH THE STRUT TUBE BROKEN. THE ARTICULATING SHEATH (ADS) WAS RELAXED. THE INNER MEMBER WAS RETURNED WITHOUT VISIBLE DAMAGES UNDER THE REAR HANDLE SHELLS. FLUSHING WAS ACHIEVED IN ALL FLUSH PORTS. MICROSCOPIC INSPECTION OF THE DEVICE REVEALED NO DAMAGES TO THE DISTAL FILTER MEMBER. THE LOCATION OF THE STRUT TUBE BREAK WAS CONFIRMED. A TEST GUIDE WIRE WAS FULLY INSERTED FOR FUNCTIONAL TESTING. THE PROXIMAL FILTER SHEATHED AND UN-SHEATHED USING THE PROXIMAL FILTER SLIDER (#1). THE ADS RESPONDED AS EXPECTED WHEN TURNING THE ARTICULATING KNOB (#2). THE DISTAL FILTER SLIDER (#3) WAS PULLED AND NO FRICTION WAS FELT; HOWEVER, SHEATHING OF THE DISTAL FILTER WAS STOPPED DUE TO THE STRUT TUBE DAMAGE.

    Description of Event or Problem · 1

    REPORTABLE ON RETURNED DEVICE ANALYSIS COMPLETED 18 SEPT 2020. A 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
    1054102 SENTINEL CEREBRAL PROTECTION SYSTEM (US) EMBOLIC PROTECTION DEVICE PUM CLARET MEDICAL, INC. CMS15-10C-US

    Patients

    Seq Age Sex Outcome Treatment
    1