BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURFACER INSIDE-OUT ACCESS CATHETER SYSTEM

    MDR report key: 16573078 · Received March 17, 2023

    Report

    Report Number
    MW5115813
    Event Type
    Injury
    Date Received
    March 17, 2023
    Date of Event
    February 14, 2023
    Report Date
    March 15, 2023
    Manufacturer
    BLUEGRASS VASCULAR TECHNOLOGIES, INC.
    Product Code
    QJH
    UDI-DI
    00860003451601
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PER THE INTENDED USE OF THE DEVICE, RIGHT FEMORAL VEIN ACCESS WAS OBTAINED, THE SURFACER 10FR WORKSTATION WAS ADVANCED OVER THE GUIDEWIRE WIRE AND POSITIONED WITHIN THE STUMP OF THE OCCLUSION. USING FLUOROSCOPY FOR VISUALIZATION, THE SURFACER DEVICE WAS INTRODUCED INTO THE 10F WORKSTATION. THE SURFACER DEVICE WAS THEN ADVANCED THROUGH THE OCCLUSION UNTIL THE DEVICE TIP AND WINDOW WERE ABOVE THE CLAVICLE. THE C-ARM WAS ADJUSTED TO LOCALIZE THE TIP OF THE DEVICE WITHIN THE CENTER OF THE EXTERNALLY PLACED TARGET. THE DEVICE WAS ADJUSTED, THE NEEDLE GUIDE WAS DEPLOYED AND NEEDLE WIRE ADVANCED. A 7F SHEATH WAS ADVANCED OVER THE WIRE AND SECURED USING A HEMOSTAT. THE CATHETER WAS THEN PULLED INTO THE BODY WITH THE TIP POSITIONED IN THE RIGHT ATRIUM BY RETRACTING THE SURFACER DEVICE. A POST-PROCEDURE ULTRASOUND OF THE NECK IDENTIFIED A HEMATOMA AND CATHETER POSITION WAS DEEMED SUBOPTIMAL. AFTER MANIPULATING CATHETER, THE HEMATOMA APPEARED TO BE ENLARGED. THE CATHETER WAS REMOVED AND THE ARTERIAL DEFECT REPAIRED BY BALLOON TAMPONADE. BALLOON WAS INFLATED TO NOMINAL PRESSURE AND MAINTAINED FOR 10 MINUTES. UPON BALLOON DEFLATION, ARTERIOGRAM SHOWED NO CONTRAST EXTRAVASATION AT THE SITE OF DEFECT. THE PATIENT WAS OBSERVED FOR ANOTHER 15 MINUTES AND A REPEAT ANGIOGRAM CONFIRMED HEMOSTASIS AT THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825140 SURFACER INSIDE-OUT ACCESS CATHETER SYSTEM REVERSE CENTRAL VENOUS RECANALIZATION SYSTEM QJH BLUEGRASS VASCULAR TECHNOLOGIES, INC. 600200/A BVT042622-01 00860003451601

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention