BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINEL CEREBRAL PROTECTION SYSTEM (US)

    MDR report key: 10247487 · Received July 8, 2020

    Report

    Report Number
    2134265-2020-09015
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    June 23, 2020
    Report Date
    July 8, 2020
    Manufacturer
    CLARET MEDICAL, INC.
    Product Code
    PUM
    UDI-DI
    00863229000004
    PMA / PMN Number
    DEN160043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS ESTIMATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTAL FILTER WAS UNABLE TO BE RESHEATHED. A SENTINEL EMBOLIC PROTECTION DEVICE HAD BEEN PLACED. WHEN ATTEMPTING TO RETRACT THE DISTAL FILTER, THE DISTAL FILTER SLIDE ON THE HANDLE BROKE. THE PHYSICIAN WAS UNABLE TO RESHEATH THE DISTAL FILTER PRIOR TO REMOVING THE SENTINEL EMBOLIC PROTECTION DEVICE FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711340 SENTINEL CEREBRAL PROTECTION SYSTEM (US) EMBOLIC PROTECTION DEVICE PUM CLARET MEDICAL, INC. CMS15-10C-US 0025150922 00863229000004

    Patients

    Seq Age Sex Outcome Treatment
    1