BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 2133572 · Received June 16, 2011

    Report

    Report Number
    3003603429-2011-00026
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 15, 2011
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES, INC.
    Product Code
    MCW
    PMA / PMN Number
    K101221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATHWAY JETSTREAM G3 CATHETER WAS DISCARDED AFTER THE PROCEDURE AND THEREFORE NOT RETURNED TO PATHWAY MEDICAL TECHNOLOGIES FOR EVALUATION. DISTAL EMBOLIZATION IS AN INHERENT RISK FOR THE TREATMENT OF PERIPHERAL VASCULAR DISEASE WITH PATHWAY MEDICAL'S JETSTREAM G3 SYSTEM AND IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE IFU. LASTLY, THE GUIDEWIRE USED IN THIS CASE IS A SPIDER FILTER GUIDEWIRE WHICH IS NOT A COMPATIBLE ACCESSORY AND THE IFU INCLUDES A CAUTION REGARDING THE USE OF GUIDEWIRES NOT LISTED FOR USE, "USE ONLY LISTED COMPATIBLE GUIDEWIRES AND INTRODUCERS WITH THE JETSTREAM G3 SYSTEM. USE OF ANY SUPPLIES NOT LISTED AS COMPATIBLE MAY COMPROMISE PERFORMANCE OF OR DAMAGE THE JETSTREAM G3 SYSTEM."

    Description of Event or Problem · 1

    THE JETSTREAM G3 WAS ADVANCED TO TREAT A 25 CM LESION LOCATED IN THE PROXIMAL TO DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). MINIMUM DIAMETER MODE WAS USED FOR THE ENTIRE LENGTH OF THE LESION, ENCOUNTERING SOME INTERMITTENT RESISTANCE, HOWEVER, ASPIRATION WAS WORKING EFFECTIVELY. THE DEVICE WAS REMOVED AND AN ANGIOGRAM REVEALED AN OPEN CHANNEL THROUGH THE ENTIRE SFA WITH GOOD RUNOFF. A SECOND PASSING USING THE MAXIMUM DIAMETER MODE WAS A LITTLE MORE CHALLENGING DUE TO THE FREQUENT MOVEMENT OF THE SPIDER BASKET. TOWARDS THE END OF THE PASS, IT WAS NOTICED THAT THE ASPIRATION TUBING APPEARED CLOGGED. THE DEVICE WAS REMOVED AND AN ANGIOGRAM REVEALED AN OCCLUDED SFA. THE CATHETER WAS ADVANCED TO THE DISTAL POPLITEAL WHICH SHOWED AN OCCLUDED OUTFLOW CAUSED BY A CLOT IN THE TIBIAL PERONEAL TRUNK, HOWEVER, RETROGRADE FLOW OF THE CONTRAST DURING THAT RUN, SHOWED A PATENT SFA. PATIENT WAS PUT ON LYTICS AND SENT TO THE ICU. THE CLOT WAS TREATED WITH AN ASPIRATION CATHETER AND LYTICS AND THE PATIENT'S CONDITION CLEARED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES, INC. PV31300 110223

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention