BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELSIOR XT-27 STD STRAIGHT 150CM

    MDR report key: 19882752 · Received August 1, 2024

    Report

    Report Number
    19882752
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    March 12, 2024
    Report Date
    April 21, 2024
    Manufacturer
    STRYKER NEUROVASCULAR
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE DISTAL PLATINUM MARKER BAND OF AN XT-27 MICROCATHETER (MADE BY STRYKER NEUROVASCULAR) DETACHED DURING REMOVAL OF THE EVOLVE FLOW DIVERTER DELIVERY SYSTEM. THE MARKER BAND GOT LOOSE AND FELL OFF. THE MARKER WAS SEEN ON FINAL IMAGING IN THE DISTAL MCA VESSELS. THE PATIENT WOKE UP FROM THE PROCEDURE AND DID WELL. NO ADVERSE EFFECTS OF THE MARKER BAND WERE NOTED. THE CATHETER WAS GIVEN TO STRYKER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2250065 EXCELSIOR XT-27 STD STRAIGHT 150CM CATHETER, PERCUTANEOUS DQY STRYKER NEUROVASCULAR M003XT2750810 24494366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown