BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEB SINGLE LAYER-USA W2-9-4

    MDR report key: 8952735 · Received August 30, 2019

    Report

    Report Number
    2032493-2019-00203
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Date of Event
    July 31, 2019
    Report Date
    July 31, 2019
    Manufacturer
    SEQUENT MEDICAL, INC
    Product Code
    OPR
    UDI-DI
    00856956005985
    PMA / PMN Number
    P170032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED. THE MANUFACTURING RECORDS WERE REVIEWED. ALL INSPECTION VALUES WERE WITHIN SPECIFICATION AND THERE WERE NO NCR'S OR DEVIATIONS. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN ANALYSIS COULD NOT BE CONDUCTED. THE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WEB DEVICE WAS SUCCESSFULLY DETACHED WITHIN AN ANEURYSM, BUT THE PUSHER WIRE WAS ADVANCED FORWARD, INVAGINATING THE WEB DEVICE AND PUSHING IT CLOSER TO THE DOME OF THE ANEUYSM. A SNARE WAS USED TO PULL THE WEB BACK INTO PLACE. THERE WAS NO REPORTED ADVERSE CLINICAL SEQUELA TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746099 WEB SINGLE LAYER-USA W2-9-4 WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM OPR SEQUENT MEDICAL, INC FGA15090-040 19052950 00856956005985

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention