BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINEL CEREBRAL PROTECTION SYSTEM (US)

    MDR report key: 10312724 · Received July 23, 2020

    Report

    Report Number
    2134265-2020-09320
    Event Type
    Malfunction
    Date Received
    July 23, 2020
    Date of Event
    June 11, 2020
    Report Date
    September 9, 2020
    Manufacturer
    CLARET MEDICAL, INC.
    Product Code
    PUM
    UDI-DI
    00863229000004
    PMA / PMN Number
    DEN160043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B5 DESCRIBE EVENT OR PROBLEM: UPDATED. H3 DEVICE EVALUATED BY MANUFACTURER: THE SENTINEL DEVICE WAS RETURNED WITH AN UNIDENTIFIED GUIDEWIRE (NOT INSIDE THE SENTINEL). THE DISTAL FILTER SLIDER WAS BENT. THE OUTER SHEATH TRANSITION TUBE WAS KINKED. THERE WERE MULTIPLE KINKS AND BENTS THROUGHOUT THE WHOLE OUTER SHEATH LENGTH. AN INTRODUCER SHEATH WAS RETURNED STUCK ON THE DEVICE AND APPEARED TO HAVE BEEN BUCKLED AT SOME POINT. THE TIP WAS NOT RETURNED. THE DISTAL FILTER MEMBRANE WAS DETACHED FROM THE TIP OF THE TRI-LAYER. THE TRI-LAYER WAS ELONGATED, PINCHED AND TWISTED. THE ARTICULATING DISTAL SHEATH (ADS) WAS FLEXED AND PINCHED; AND FELT "BUMPY". THE OUTER SHEATH TIP WAS BUCKLED AND BEGINNING TO SPLIT. THE PROXIMAL FILTER WAS STUCK IN THE OUTER SHEATH TIP. NO INNER MEMBER DAMAGES WERE VISIBLE UNDER THE REAR HANDLE SHELLS. FLUSHING WAS PERFORMED THROUGH THE INTRODUCER SHEATH FLUSH PORT AND REMOVAL WAS ATTEMPTED, HOWEVER ONCE IT GOT TO THE TIP IT GOT STUCK AGAIN. THE INTRODUCER SHEATH WAS CUT IN ORDER TO RELEASE THE SENTINEL DEVICE; THE OVERALL CONDITION OF THE SENTINEL DEVICE WAS NOT ALTERED BY THE CUTTING OF THE INTRODUCER SHEATH. MICROSCOPIC INSPECTION OF THE KINKS AND DAMAGES WAS TAKEN; WEAR MARKS, TWISTING, PINCHES AND BREAK LOCATIONS WERE CONFIRMED. X-RAY INSPECTION REVEALED MULTIPLE KINKS AND BENTS, MATCHING THE LOCATION OF THOSE IN THE OUTER SHEATH. THERE WAS NO VISIBLE PROXIMAL FILTER DAMAGES. THE DISTAL FILTER FRAME APPEARED TO BE KINKED. THE DISTAL FILTER COUPLER WAS UNRAVELED. THE ADS DAMAGE WAS CONFIRMED. DUE TO THE CONDITION IN WHICH THE DEVICE WAS RECEIVED, NO FUNCTIONAL TESTS COULD BE PERFORMED. H6 DEVICE CODES: UPDATED.

    Additional Manufacturer Narrative · 0

    D10 DEVICE AVAILABLE FOR EVALUATION, RETURNED TO MANUFACTURER DATE - UPDATED H3 DEVICE RETURNED TO MFR - UPDATED H3 DEVICE EVALUATED BY MANUFACTURER: THE SENTINEL DEVICE WAS RETURNED WITH AN UNIDENTIFIED GUIDEWIRE (NOT INSIDE THE SENTINEL). THE DISTAL FILTER SLIDER WAS BENT. THE OUTER SHEATH TRANSITION TUBE WAS KINKED. THERE WERE MULTIPLE KINKS AND BENTS THROUGHOUT THE WHOLE OUTER SHEATH LENGTH. AN INTRODUCER SHEATH WAS RETURNED STUCK ON THE DEVICE AND APPEARED TO HAVE BEEN BUCKLED AT SOME POINT. THE TIP WAS NOT RETURNED. THE DISTAL FILTER MEMBRANE WAS DETACHED FROM THE TIP OF THE TRI-LAYER. THE TRI-LAYER WAS ELONGATED, PINCHED AND TWISTED. THE ARTICULATING DISTAL SHEATH (ADS) WAS FLEXED AND PINCHED; AND FELT "BUMPY". THE OUTER SHEATH TIP WAS BUCKLED AND BEGINNING TO SPLIT. THE PROXIMAL FILTER WAS STUCK IN THE OUTER SHEATH TIP. NO INNER MEMBER DAMAGES WERE VISIBLE UNDER THE REAR HANDLE SHELLS. FLUSHING WAS PERFORMED THROUGH THE INTRODUCER SHEATH FLUSH PORT AND REMOVAL WAS ATTEMPTED, HOWEVER ONCE IT GOT TO THE TIP IT GOT STUCK AGAIN. THE INTRODUCER SHEATH WAS CUT IN ORDER TO RELEASE THE SENTINEL DEVICE; THE OVERALL CONDITION OF THE SENTINEL DEVICE WAS NOT ALTERED BY THE CUTTING OF THE INTRODUCER SHEATH. MICROSCOPIC INSPECTION OF THE KINKS AND DAMAGES WAS TAKEN; WEAR MARKS, TWISTING, PINCHES AND BREAK LOCATIONS WERE CONFIRMED. X-RAY INSPECTION REVEALED MULTIPLE KINKS AND BENTS, MATCHING THE LOCATION OF THOSE IN THE OUTER SHEATH. THERE WAS NO VISIBLE PROXIMAL FILTER DAMAGES. THE DISTAL FILTER FRAME APPEARED TO BE KINKED. THE DISTAL FILTER COUPLER WAS UNRAVELED. THE ADS DAMAGE WAS CONFIRMED. DUE TO THE CONDITION IN WHICH THE DEVICE WAS RECEIVED, NO FUNCTIONAL TESTS COULD BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE RESHEATHED. THE PATIENT'S ANATOMY WAS TORTUOUS. RADIAL ACCESS WAS GAINED AND A SENTINEL CEREBRAL PROTECTION SYSTEM WAS ADVANCED. THE PROXIMAL FILTER WAS DEPLOYED, HOWEVER, THERE WAS DIFFICULTY IN CANNULATING THE LEFT SUBCLAVIAN ARTERY WITH THE DISTAL FILTER. THEY PHYSICIANS DECIDED TO REMOVE THE DEVICE AND UPON REMOVAL THE SENTINEL SYSTEM BECAME STUCK OUTSIDE THE INTRODUCER SHEATH. IT APPEARED THAT THE PROXIMAL FILTER WAS NOT FULLY RETRACTED. THE SENTINEL SYSTEM HANDLE WAS NOT ENGAGING WITH THE DISTAL END OF THE DEVICE. THE SENTINEL SYSTEM, INTRODUCER SHEATH AND GUIDEWIRE WERE REMOVED TOGETHER. ONCE REMOVED FROM THE PATIENT, IT WAS NOTED THAT THE PROXIMAL FILTER WAS TORN. THE TIP OF THE DEVICE BECAME DETACHED WHILE TRYING TO REMOVE FROM RADIAL SHEATH. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS FINE. IT WAS FURTHER REPORTED THAT THE TIP OF THE DEVICE WAS BROKEN OFF WHILE TRYING TO REMOVE THE DEVICE FROM THE RADIAL SHEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE RESHEATHED. THE PATIENT'S ANATOMY WAS TORTUOUS. RADIAL ACCESS WAS GAINED AND A SENTINEL CEREBRAL PROTECTION SYSTEM WAS ADVANCED. THE PROXIMAL FILTER WAS DEPLOYED, HOWEVER, THERE WAS DIFFICULTY IN CANNULATING THE LEFT SUBCLAVIAN ARTERY WITH THE DISTAL FILTER. THEY PHYSICIANS DECIDED TO REMOVE THE DEVICE AND UPON REMOVAL THE SENTINEL SYSTEM BECAME STUCK OUTSIDE THE INTRODUCER SHEATH. IT APPEARED THAT THE PROXIMAL FILTER WAS NOT FULLY RETRACTED. THE SENTINEL SYSTEM HANDLE WAS NOT ENGAGING WITH THE DISTAL END OF THE DEVICE. THE SENTINEL SYSTEM, INTRODUCER SHEATH AND GUIDEWIRE WERE REMOVED TOGETHER. ONCE REMOVED FROM THE PATIENT, IT WAS NOTED THAT THE PROXIMAL FILTER WAS TORN. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE RESHEATHED. THE PATIENT'S ANATOMY WAS TORTUOUS. RADIAL ACCESS WAS GAINED AND A SENTINEL CEREBRAL PROTECTION SYSTEM WAS ADVANCED. THE PROXIMAL FILTER WAS DEPLOYED, HOWEVER, THERE WAS DIFFICULTY IN CANNULATING THE LEFT SUBCLAVIAN ARTERY WITH THE DISTAL FILTER. THEY PHYSICIANS DECIDED TO REMOVE THE DEVICE AND UPON REMOVAL THE SENTINEL SYSTEM BECAME STUCK OUTSIDE THE INTRODUCER SHEATH. IT APPEARED THAT THE PROXIMAL FILTER WAS NOT FULLY RETRACTED. THE SENTINEL SYSTEM HANDLE WAS NOT ENGAGING WITH THE DISTAL END OF THE DEVICE. THE SENTINEL SYSTEM, INTRODUCER SHEATH AND GUIDEWIRE WERE REMOVED TOGETHER. ONCE REMOVED FROM THE PATIENT, IT WAS NOTED THAT THE PROXIMAL FILTER WAS TORN. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777600 SENTINEL CEREBRAL PROTECTION SYSTEM (US) EMBOLIC PROTECTION DEVICE PUM CLARET MEDICAL, INC. CMS15-10C-US 0024954997 00863229000004

    Patients

    Seq Age Sex Outcome Treatment
    1