BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINEL CEREBRAL PROTECTION SYSTEM (US)

    MDR report key: 8024993 · Received October 31, 2018

    Report

    Report Number
    2134265-2018-62071
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    October 10, 2018
    Report Date
    December 7, 2018
    Manufacturer
    CLARET MEDICAL, INC.
    Product Code
    PUM
    UDI-DI
    00863229000004
    PMA / PMN Number
    DEN160043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TYPE OF REPORTABLE EVENT CORRECTED FROM SERIOUS INJURY TO MALFUNCTION .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON REMOVAL THE DISTAL FILTER WAS DEPLOYED. A SENTINEL EMBOLIC PROTECTION DEVICE WAS POSITIONED AND DEPLOYMENT WENT "GREAT". DURING REMOVAL, THE DISTAL FILTER WAS DEPLOYED SOMEWHERE IN THE ARM FROM THE SHOULDER TO THE RADIAL WHERE IT CAME OUT AND WAS NOTED TO BE DEPLOYED. IT IS UNKNOWN IF THE DEVICE WAS EITHER ACCIDENTALLY BUMPED OR CAUGHT ON THE DRAPE ON THE TABLE. THERE WERE NO REMOVAL DIFFICULTIES NOTED. TWO HOURS POST PROCEDURE, THE PATIENT EXPERIENCES EXPRESSIVE APHASIA AND WAS TAKEN TO CT FOR IMAGING. THE PATIENT WAS ABLE TO MOVE ALL LIMBS, BUT UNABLE TO SPEAK. IN THE PHYSICIAN'S OPINION, THEY DO NOT BELIEVE THE SENTINEL DEVICE WAS RESPONSIBLE FOR THE STOKE ESPECIALLY SINCE THE IMAGES SHOWED A LEFT SIDED LESION. THE PATIENT WAS NOT GIVEN TPA DUE TO PATIENT HISTORY AND THE GROINS BEING SUSCEPTIBLE TO BLEEDING FROM THE SHEATHS. THE PATIENT IS STILL EXPERIENCING EXPRESSIVE APHASIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON REMOVAL THE DISTAL FILTER WAS DEPLOYED. A SENTINEL EMBOLIC PROTECTION DEVICE WAS POSITIONED AND DEPLOYMENT WENT "GREAT". DURING REMOVAL, THE DISTAL FILTER WAS DEPLOYED SOMEWHERE IN THE ARM FROM THE SHOULDER TO THE RADIAL WHERE IT CAME OUT AND WAS NOTED TO BE DEPLOYED. IT IS UNKNOWN IF THE DEVICE WAS EITHER ACCIDENTALLY BUMPED OR CAUGHT ON THE DRAPE ON THE TABLE. THERE WERE NO REMOVAL DIFFICULTIES NOTED. TWO HOURS POST PROCEDURE, THE PATIENT EXPERIENCES EXPRESSIVE APHASIA AND WAS TAKEN TO CT FOR IMAGING. THE PATIENT WAS ABLE TO MOVE ALL LIMBS, BUT UNABLE TO SPEAK. IN THE PHYSICIAN'S OPINION, THEY DO NOT BELIEVE THE SENTINEL DEVICE WAS RESPONSIBLE FOR THE STOKE ESPECIALLY SINCE THE IMAGES SHOWED A LEFT SIDED LESION. THE PATIENT WAS NOT GIVEN TPA DUE TO PATIENT HISTORY AND THE GROINS BEING SUSCEPTIBLE TO BLEEDING FROM THE SHEATHS. THE PATIENT IS STILL EXPERIENCING EXPRESSIVE APHASIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864790 SENTINEL CEREBRAL PROTECTION SYSTEM (US) EMBOLIC PROTECTION DEVICE PUM CLARET MEDICAL, INC. CMS15-10C-US 18H28H22 00863229000004

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR