BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINEL CEREBRAL PROTECTION SYSTEM (US)

    MDR report key: 8168582 · Received December 17, 2018

    Report

    Report Number
    2134265-2018-64225
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    November 29, 2018
    Report Date
    February 26, 2019
    Manufacturer
    CLARET MEDICAL, INC.
    Product Code
    PUM
    UDI-DI
    00863229000004
    PMA / PMN Number
    DEN160043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: TYPE OF REPORTABLE EVENT FROM SERIOUS INJURY TO MALFUNCTION.

    Additional Manufacturer Narrative · 0

    DEVICE MANUFACTURER ANALYSIS: ANALYSIS OF RETURNED PRODUCT REVEALED THAT THE DISTAL FILTER IS DETACHED, THIS IS CONSISTENT WITH THE REPORTED ALLEGATION, CONSEQUENTLY, CONFIRMING THE REPORTED COMPLAINT. ADDITIONALLY, #3 HUB IS SLIGHTLY BENT. THE DEVICE WAS INSPECTED UNDER MICROSCOPE AND SHOWS CLEAN LINES, APPEARS TO BE CUT IN THE DETACHED SECTION OF THE FILTER. HOWEVER, THERE IS NOT ENOUGH EVIDENCE THAT ALLOWS TO DETERMINE WHAT COULD HAVE CONTRIBUTED TO DETACHMENT OF THE FILTER AND BENT CONDITION OF THE #3 HUB. THE DHR REVIEW WAS PERFORMED AND SHOWS THAT ALL ACCEPTANCE RECORDS DEMONSTRATE THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. CAUSE NOT ESTABLISHED WAS SELECTED AS THE MOST PROBABLE CAUSE OF THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DISTAL FILTER DETACHED. DURING PREPARATION, WHILE THE DISTAL FILTER WAS SUBMERGE AND BEING AGITATED TO REMOVED THE AIR BUBBLES, THE DISTAL FILTER DETACHED. THE DETACHED FILTER WAS ALSO NOTED TO HAVE FOLDED INSIDE OUT. THE DEVICE WAS NOT USED INSIDE THE PATIENT AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DISTAL FILTER DETACHED. DURING PREPARATION, WHILE THE DISTAL FILTER WAS SUBMERGE AND BEING AGITATED TO REMOVED THE AIR BUBBLES, THE DISTAL FILTER DETACHED. THE DETACHED FILTER WAS ALSO NOTED TO HAVE FOLDED INSIDE OUT. THE DEVICE WAS NOT USED INSIDE THE PATIENT AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DISTAL FILTER DETACHED. DURING PREPARATION, WHILE THE DISTAL FILTER WAS SUBMERGE AND BEING AGITATED TO REMOVED THE AIR BUBBLES, THE DISTAL FILTER DETACHED. THE DETACHED FILTER WAS ALSO NOTED TO HAVE FOLDED INSIDE OUT. THE DEVICE WAS NOT USED INSIDE THE PATIENT AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008941 SENTINEL CEREBRAL PROTECTION SYSTEM (US) EMBOLIC PROTECTION DEVICE PUM CLARET MEDICAL, INC. CMS15-10C-US 18L06H12 00863229000004

    Patients

    Seq Age Sex Outcome Treatment
    1