BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINEL CEREBRAL PROTECTION SYSTEM (US)

    MDR report key: 10347645 · Received July 30, 2020

    Report

    Report Number
    2134265-2020-09603
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    July 9, 2020
    Report Date
    July 30, 2020
    Manufacturer
    CLARET MEDICAL, INC.
    Product Code
    PUM
    UDI-DI
    00863229000004
    PMA / PMN Number
    DEN160043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOSS OF POSITION OCCURRED. A SENTINEL CEREBRAL PROTECTION SYSTEM WAS IN USE DURING A TRANSAORTIC VALVE REPLACEMENT PROCEDURE. DURING THE PROCEDURE THE PATIENT MOVED THEIR RIGHT ARM CAUSING THE DISTAL AND PROXIMAL FILTERS TO LOSE POSITION. THE FILTERS WERE RESHEATHED AND THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. THE PATIENT CONDITION WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807640 SENTINEL CEREBRAL PROTECTION SYSTEM (US) EMBOLIC PROTECTION DEVICE PUM CLARET MEDICAL, INC. CMS15-10C-US 0025086338 00863229000004

    Patients

    Seq Age Sex Outcome Treatment
    1