BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINEL CEREBRAL PROTECTION SYSTEM (US)

    MDR report key: 10284770 · Received July 16, 2020

    Report

    Report Number
    2134265-2020-09450
    Event Type
    Malfunction
    Date Received
    July 16, 2020
    Date of Event
    June 25, 2020
    Report Date
    July 16, 2020
    Manufacturer
    CLARET MEDICAL, INC.
    Product Code
    PUM
    UDI-DI
    00863229000004
    PMA / PMN Number
    DEN160043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROXIMAL FILTER WAS UNABLE TO BE RESHEATHED. THE PATIENT'S ANATOMY CONTAINED A MEDIUM LEVEL OF TORTUOSITY AND A MEDIUM LEVEL OF CALCIUM. A SENTINEL EMBOLIC PROTECTION SYSTEM WAS ADVANCED OVER A CHOICE PT EXTRA SUPPORT WIRE. THE PROXIMAL FILTER OF THE SENTINEL EMBOLIC PROTECTION SYSTEM WAS ABLE TO BE DEPLOYED. THE PHYSICIAN WAS NOT ABLE TO DEPLOY THE DISTAL FILTER OF THE SENTINEL EMBOLIC PROTECTION SYSTEM. AT THE END OF THE PROCEDURE, THE PROXIMAL FILTER WAS NOT ABLE TO BE FULLY RESHEATHED BEFORE REMOVAL FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750220 SENTINEL CEREBRAL PROTECTION SYSTEM (US) EMBOLIC PROTECTION DEVICE PUM CLARET MEDICAL, INC. CMS15-10C-US 0025293855 00863229000004

    Patients

    Seq Age Sex Outcome Treatment
    1