BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 1947347 · Received December 29, 2010

    Report

    Report Number
    3003603429-2010-00056
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 29, 2010
    Manufacturer
    PATHWAY MED TECHNOLOGIES, INC.
    Product Code
    MCW
    PMA / PMN Number
    K101221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 EVAL. DISSECTION 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. IN-STENT RESTENOSIS PT 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 PTS) IN THE IFU.

    Description of Event or Problem · 1

    THE JETSTREAM G3 WAS ADVANCED TO TREAT A 20 CM IN-STENT RESTENOSIS (ISR) LESION LOCATED IN THE MID-DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). ONE PASS WAS MADE IN THE MINIMUM DIAMETER MODE AND ONE PASS WAS MADE IN THE MAXIMUM DIAMETER MODE. WHILE COMING BACK UP IN THE MAXIMUM DIAMETER MODE, THE DEVICE BECAME STUCK ON THE GUIDEWIRE. TWO DISSECTIONS IN THE TIBIAL OCCURRED FROM THE GUIDEWIRE SPINNING. THE DISSECTIONS WERE TREATED USING PTA WITH FAIR RESULTS. PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MED TECHNOLOGIES, INC. PV31300 100824

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention