BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 2091596 · Received April 28, 2011

    Report

    Report Number
    3003603429-2011-00020
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 28, 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 RETURNED DEVICE WAS EVALUATED AND THE CAUSE OF THE JETSTREAM G3'S ISSUE WITH ASPIRATION WAS DUE TO ISSUE OCCLUDING THE ASPIRATION LUMEN. 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. THE DEVICE WAS NOT USED PER THE IFU. IT WAS REPORTED THAT THE RUN TIME FOR THE DEVICE WAS 11 MINUTES 46 SECONDS. THERE IS A NOTE IN THE IFU REGARDING RUN TIME: "THE JETSTREAM G3 CATHETER USE TIME SHOULD NOT EXCEED 10 MINUTES. MONITOR THE TIMER ON THE PV CONSOLE AND USE A SECOND DEVICE IF ADDITIONAL TREATMENT IS REQUIRED." ADDITIONALLY, IN-STENT RESTENOSIS PATIENTS ARE LISTED AS A SPECIAL PT POPULATION (I.E., THE SAFETY AND EFFECTIVENESS OF THE JETSTREAM G3 SYSTEM HAS NOT BEEN ESTABLISHED IN THIS GROUP OF PATIENTS) IN THE IFU. LASTLY, THE GUIDEWIRE USED IN THIS CASE IS A BAREWIRE 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 AN APPROXIMATELY 40 CM IN-STENT RESTENOSIS (ISR) LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). TWO PASSES WERE MADE USING THE MINIMUM DIAMETER MODE AND THE MAXIMUM DIAMETER MODE. SLOWING IN ASPIRATION WAS NOTED TOWARD THE END OF THE CASE. UPON REMOVAL, THE DEVICE BECAME STUCK ON THE GUIDEWIRE AND BOTH WERE REMOVED AS A UNIT FROM THE PT. DISTAL EMBOLIZATION OCCURRED AND PARTIALLY RETRIEVED. SLUGGISH FLOW BELOW THE KNEE, HOWEVER, PT APPEARED TO BE 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 110303

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention