BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 1911066 · Received November 24, 2010

    Report

    Report Number
    3003603429-2010-00048
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 24, 2010
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES, INC.
    Product Code
    MCW
    PMA / PMN Number
    K101221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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.

    Description of Event or Problem · 1

    THE JETSTREAM G3 WAS ADVANCED TO TREAT A 25 CM LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE WAS ACTIVATED AT THE ORIGIN OF THE SFA AND ADVANCED SLOWLY USING A BACK/FORTH MOTION IN AN ANTEGRADE DIRECTION. THE DEVICE STALLED SEVERAL TIMES IN DIFFERENT PORTIONS OF THE DISEASED VESSEL. EACH TIME, THE PHYSICIAN BACKED-UP AND THEN ADVANCED SLOWLY UNTIL THE DEVICE PASSED. THE DEVICE WAS THEN RETRACTED BACK AFTER ADVANCING TO THE MID SFA REGION. A SECOND PASS WAS INITIATED, USING MINIMUM DIAMETER MODE. THE PHYSICIAN THEN DECIDED TO CHECK THE POSITION OF THE GUIDEWIRE. AFTER LOCATING THE DISTAL TIP OF THE GUIDEWIRE, THE PHYSICIAN NOTED THAT THE RADIO-OPAQUE PORTION OF THE GUIDEWIRE SEEMED TO BE TOO SHORT. FURTHER SCANNING REVEALED THE DISTAL PORTION OF THE GUIDEWIRE TO BE LODGED IN A BRANCH OF THE PERONEAL SLIGHTLY ABOVE THE ANKLE. IT WAS DECIDED TO NOT RETRIEVE THE EMBOLIZED GUIDEWIRE SINCE IT DID NOT OBSTRUCT FLOW. THE DEVICE WAS REMOVED FROM THE PT. AFTER REMOVING THE JETSTREAM G3, IT WAS NOTED THERE WAS A DISSECTION WHERE THE PHYSICIAN BELIEVED A PORTION OF THE RECANALIZATION WAS SUBINTIMAL. THE DISSECTION WAS SUCCESSFULLY TREATED WITH A STENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR