BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINEL CEREBRAL PROTECTION SYSTEM

    MDR report key: 10534714 · Received September 15, 2020

    Report

    Report Number
    2134265-2020-12453
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    August 31, 2020
    Report Date
    November 6, 2020
    Manufacturer
    CLARET MEDICAL, INC.
    Product Code
    PUM
    PMA / PMN Number
    DEN160043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3 DEVICE EVALUATED BY MFR: UNIT RETURNED IN A GENERIC PLASTIC BAG, OVERALL VISUAL REVISION DID NOT IDENTIFY FAILURES OR EVIDENCE THAT COULD BE LOST DUE TO DECONTAMINATION PROCESS. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THE UNIT WAS RETURNED WITH THE FOLLOWING CONDITIONS: THE DISTAL FILTER SLIDER (#3) KINKED, THE PROXIMAL FILTER SHEATHED AND THE DISTAL FILTER UN-SHEATHED. XRAY INSPECTION REVEALED CLEAN DETACHMENT OF THE INNER MEMBER FROM THE HYPOTUBE. FLUSHING WAS ACHIEVED AS EXPECTED THROUGH DISTAL FILTER SLIDER (#3). THE DISTAL FILTER COULD NOT BE SHEATHED/UN-SHEATHED DUE TO CLEAN DETACHMENT OF THE INNER MEMBER FROM THE HYPOTUBE IN DISTAL FILTER SLIDER (#3).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INABILITY TO RESHEATH THE DISTAL FILTER OCCURRED. A SENTINEL EMBOLIC PROTECTION DEVICE WAS PLACED FOR USE DURING A TRANSCATHETER AORTIC VALVE IMPLANT (TAVI) PROCEDURE. THE PROXIMAL AND DISTAL FILTERS WERE SUCCESSFULLY DEPLOYED. AFTER THE TAVI PROCEDURE, THE PHYSICIAN WAS ATTEMPTING TO RESHEATH THE DISTAL FILTER WHEN THE DISTAL FILTER SLIDER BROKE OFF THE HANDLE OF THE SENTINEL EMBOLIC PROTECTION SYSTEM. THE PHYSICIAN WAS UNABLE TO RESHEATH THE DISTAL FILTER. THE PHYSICIAN WAS ABLE TO RESHEATH THE PROXIMAL FILTER WITHOUT ANY ISSUE. THE SENTINEL EMBOLIC PROTECTION DEVICE WAS REMOVED FROM THE PATIENT OVER THE GUIDE WIRE WITH THE DISTAL FILTER UNSHEATHED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT HAS FULLY RECOVERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INABILITY TO RESHEATH THE DISTAL FILTER OCCURRED. A SENTINEL EMBOLIC PROTECTION DEVICE WAS PLACED FOR USE DURING A TRANSCATHETER AORTIC VALVE IMPLANT (TAVI) PROCEDURE. THE PROXIMAL AND DISTAL FILTERS WERE SUCCESSFULLY DEPLOYED. AFTER THE TAVI PROCEDURE, THE PHYSICIAN WAS ATTEMPTING TO RESHEATH THE DISTAL FILTER WHEN THE DISTAL FILTER SLIDER BROKE OFF THE HANDLE OF THE SENTINEL EMBOLIC PROTECTION SYSTEM. THE PHYSICIAN WAS UNABLE TO RESHEATH THE DISTAL FILTER. THE PHYSICIAN WAS ABLE TO RESHEATH THE PROXIMAL FILTER WITHOUT ANY ISSUE. THE SENTINEL EMBOLIC PROTECTION DEVICE WAS REMOVED FROM THE PATIENT OVER THE GUIDE WIRE WITH THE DISTAL FILTER UNSHEATHED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT HAS FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997966 SENTINEL CEREBRAL PROTECTION SYSTEM EMBOLIC PROTECTION DEVICE PUM CLARET MEDICAL, INC. CMS15-10C 0025786902

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR