BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINEL CEREBRAL PROTECTION SYSTEM

    MDR report key: 10320424 · Received July 24, 2020

    Report

    Report Number
    2134265-2020-09824
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Date of Event
    July 16, 2020
    Report Date
    July 24, 2020
    Manufacturer
    CLARET MEDICAL, INC.
    Product Code
    PUM
    PMA / PMN Number
    DEN160043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTAL FILTER WAS UNABLE TO BE RESHEATHED. VASCULAR ACCESS WAS OBTAINED VIA RIGHT RADIAL APPROACH. A SENTINEL EMBOLIC PROTECTION DEVICE WAS POSITIONED. AT THE END OF THE PROCEDURE, WHEN ATTEMPTING TO RESHEATH THE DISTAL FILTER, THE DISTAL FILTER SLIDER BROKE. THE PHYSICIAN WAS UNABLE TO RESHEATH THE DISTAL FILTER. THE SENTINEL EMBOLIC PROTECTION DEVICE WAS REMOVED TOGETHER WITH THE RADIAL SHEATH FROM THE PATIENT WITH THE DISTAL FILTER OF THE SENTINEL EMBOLIC PROTECTION DEVICE IN A FULLY DEPLOYED STATE. NO PATIENT COMPLICATIONS WERE REPORTED. FOLLOWING THE PROCEDURE, THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783904 SENTINEL CEREBRAL PROTECTION SYSTEM EMBOLIC PROTECTION DEVICE PUM CLARET MEDICAL, INC. CMS15-10C 0025337597

    Patients

    Seq Age Sex Outcome Treatment
    1