BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXS VECTA 74 INTERMEDIATE CATHETER

    MDR report key: 17019295 · Received May 30, 2023

    Report

    Report Number
    17019295
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Date of Event
    May 7, 2023
    Report Date
    May 11, 2023
    Manufacturer
    STRYKER CORPORATION
    Product Code
    NRY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REPORT PER PHYSICIAN OPERATOR; AS HE WAS ADVANCING THE MICROCATHETER THROUGH THE VECTA 74 CATHETER, THE MICROCATHETER WOULD NOT ADVANCE, SO HER REMOVED THE MICROCATHETER UNDER IMAGING. NEXT, HE ATTEMPTED TO REMOVE THE VECTA 74 CATHETER UNDER IMAGING BUT IT WAS DIFFICULT TO REMOVE. THROUGH IMAGING, HE SAW IT WAS STUCK ON THE VESSEL WALL. PHYSICIAN CONTINUED TO REMOVE THE CATHETER AND WAS FINALLY SUCCESSFUL. UPON REMOVAL, HE DISCOVERED THE TIP WAS FRACTURED AND THEN IMMEDIATELY X-RAYED THE VESSEL AND SAW THAT THE TIP REMAINED. BECAUSE THIS WAS A STROKE PATIENT, HE DECIDED IT WAS MORE IMPORTANT TO OBTAIN TIMELY PERFUSION TO THE BRAIN AND CONTINUE WITH THE PROCEDURE INSTEAD OF TRYING TO RETRIEVE THE FRACTURED TIP. THE PHYSICIAN HAS DETERMINED THIS DEVICE ISSUE DID NOT IMPACT THE OVERALL OUTCOME OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562607 AXS VECTA 74 INTERMEDIATE CATHETER CATHETER, THROMBUS RETRIEVER NRY STRYKER CORPORATION INC-11597-132 20138-01

    Patients

    Seq Age Sex Outcome Treatment
    1 25185 DA Female