BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 1971614 · Received January 25, 2011

    Report

    Report Number
    3003603429-2011-00003
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 27, 2010
    Report Date
    January 25, 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 EVAL. THERE WAS NO INDICATION, HOWEVER, THAT THE DEVICE BECOMING STUCK ONTO THE GUIDEWIRE CAUSED THE DISTAL EMBOLIZATION. 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. IN-STENT RESTENOSIS PTS 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 AN APPROXIMATELY 40 CM IN-STENT RESTENOSIS (ISR) LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND INTO THE POPLITEAL. THE DEVICE WAS USED IN THE FIBROUS LESION FOR 34 MINUTES 10 SECONDS. THE DEVICE WOULD NOT MOVE DURING RETRACTION MODE AND THE DEVICE AND GUIDEWIRE WERE REMOVED TOGETHER AS A UNIT. DISTAL EMBOLI OCCURRED AND IT IS NOT KNOWN IF IT IS RELATED TO THE JETSTREAM G3 DEVICE. AN ASPIRATION CATHETER WAS USED TO ASPIRATE THE EMBOLI FROM THE DISTAL PERONEAL ARTERY. FLOW WAS THEN RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES INC. PV31300 101122

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention