BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINEL CEREBRAL PROTECTION SYSTEM (US)

    MDR report key: 8170490 · Received December 17, 2018

    Report

    Report Number
    2134265-2018-64033
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    November 27, 2018
    Report Date
    February 20, 2019
    Manufacturer
    CLARET MEDICAL, INC.
    Product Code
    PUM
    UDI-DI
    00863229000004
    PMA / PMN Number
    DEN160043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVAL BY MANUFACTURER: ANALYSIS OF RETURNED PRODUCT REVEALED THAT OUTER SHEATH, #3 HUB AND INNER MEMBER ARE KINK, DURING FUNCTIONAL INSPECTION THE DISTAL FILTER NOT FULLY CAPTURED. THE KINK IN OUTER SHEATH AND #3 HUB BENT WERE LIKELY DUE TO THE PACKAGING. THE INABILITY TO FULLY CAPTURE THE DISTAL FILTER IS THE BUCKLED INNER MEMBER. THE DAMAGE TO THE INNER MEMBER IS INDICATIVE OF COMPRESSIVE FORCES SO IT WAS LIKELY DAMAGE DUE TO ROUGH HANDLING DURING DEPLOYMENT OF THE DISTAL FILTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DISTAL FILTER COULD NOT BE CAPTURED. A SENTINEL CEREBRAL PROTECTION SYSTEM WAS IN USE DURING A PROCEDURE. DURING RETRIEVAL IT WAS NOTED THAT THE DISTAL FILTER WAS NOT ABLE TO BE COMPLETELY CAPTURED. THE ENTIRE SYSTEM WAS WITHDRAWN FROM THE PATIENT AND THERE WAS NO COMPLICATIONS TO THE PATIENT DUE TO THIS EVENT. IT WAS FURTHER REPORTED THAT THE DISTAL FILTER WOULD NOT COLLAPSE. THE DEVICE WAS REMOVED WITH THE DISTAL FILTER PARTIALLY OPENED AND THERE WAS DIFFICULTY IN DEVICE REMOVAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DISTAL FILTER COULD NOT BE CAPTURED. A SENTINEL CEREBRAL PROTECTION SYSTEM WAS IN USE DURING A PROCEDURE. DURING RETRIEVAL IT WAS NOTED THAT THE DISTAL FILTER WAS NOT ABLE TO BE COMPLETELY CAPTURED. THE ENTIRE SYSTEM WAS WITHDRAWN FROM THE PATIENT AND THERE WAS NO COMPLICATIONS TO THE PATIENT DUE TO THIS EVENT. IT WAS FURTHER REPORTED THAT THE DISTAL FILTER WOULD NOT COLLAPSE. THE DEVICE WAS REMOVED WITH THE DISTAL FILTER PARTIALLY OPENED AND THERE WAS DIFFICULTY IN DEVICE REMOVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SENTINEL CEREBRAL PROTECTION SYSTEM WAS IN USE DURING A PROCEDURE. DURING RETRIEVAL IT WAS NOTED THAT THE DISTAL FILTER WAS NOT ABLE TO BE COMPLETELY CAPTURED. THE ENTIRE SYSTEM WAS WITHDRAWN FROM THE PATIENT AND THERE WAS NO COMPLICATIONS TO THE PATIENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010721 SENTINEL CEREBRAL PROTECTION SYSTEM (US) EMBOLIC PROTECTION DEVICE PUM CLARET MEDICAL, INC. CMS15-10C-US 18L14H08 00863229000004

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR