BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 2447570 · Received February 9, 2012

    Report

    Report Number
    3003603429-2012-00003
    Event Type
    Injury
    Date Received
    February 9, 2012
    Date of Event
    January 19, 2012
    Report Date
    January 19, 2012
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES, INC.
    Product Code
    MCW
    PMA / PMN Number
    K110626
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED AND TISSUE CLOGGING THE ASPIRATION LUMEN WAS FOUND TO BE THE ROOT CAUSE OF THE MALFUNCTION. HOWEVER, THE CAUSE OF THE DISTAL EMBOLI WAS NOT DETERMINED. DISTAL EMBOLI IS AN INHERENT RISK FOR THE TREATMENT OF PERIPHERAL ARTERIAL DISEASE WITH PATHWAY MEDICAL'S JET STREAM G3 CATHETER AND LISTED AS A POTENTIAL ADVERSE EVENT IN THE IFU. IT IS IMPORTANT TO NOTE THAT THE DEVICE WAS NOT USED PER THE IFU. THE DEVICE WAS USED IN AN ISR. IN-STENT RESTENOSIS PTS ARE LISTED AS A SPECIAL PT POPULATION IN THE IFU AND THE SAFETY AND EFFECTIVENESS OF THE JETSTREAM SYSTEM HAS NOT BEEN ESTABLISHED IN THIS GROUP OF PTS.

    Description of Event or Problem · 1

    THE JETSTREAM NAVITUS DEVICE WAS USED TO TREAT MODERATELY CALCIFIED LESIONS THROUGHOUT THE SFA AND AN ISR. THE DEVICE RAN PROPERLY FOR ABOUT 5 MINUTES AND THEN ASPIRATION SLOWED. THE DEVICE WAS WITHDRAWN, FLUSHED AND USED AGAIN BUT, LOST ASPIRATION AGAIN. A DISTAL EMBOLI CLOSED DOWN THE PERONEAL AND ANTERIOR TIBIAL VESSEL. A JETSTREAM G3SF 1.85 WAS THEN USED TO RETRIEVE THE EMBOLI. THE PT WAS TREATED WITH LOW PRESSURE BALLOONS IN THE SFA AND TP TRUNK AND A 7X60 SPOT STENT WAS PLACED IN BETWEEN THE EXISTING STENTS. THE PT WAS REPORTED TO BE DOING WELL FOLLOWING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES, INC. 030542-004 111116

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention