BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 1634704 · Received March 17, 2010

    Report

    Report Number
    3003603429-2010-00005
    Event Type
    Injury
    Date Received
    March 17, 2010
    Date of Event
    February 15, 2010
    Report Date
    March 17, 2010
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES INC.
    Product Code
    MCW
    PMA / PMN Number
    K092332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 EVALUATION.

    Description of Event or Problem · 1

    THE JETSTREAM G3 WAS ADVANCED TO TREAT A 20CM LESION IN THE PROXIMAL TO DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). TWO PASSES WERE MADE IN MINIMUM DIAMETER MODE AND TWO PASSES WERE MADE IN MAXIMUM DIAMETER MODE. THE ASPIRATION LINE WAS CLEAR THE ENTIRE RUN TIME OF 8 MINUTES. CHECKED RUN OFF AND ALL 3 VESSEL RUN OFFS LOOKED GOOD. MADE A THIRD PASS IN THE MINIMUM DIAMETER MODE IN THE DISTAL SFA AND CHECKED RUN OFF WHICH SHOWED 3 VESSELS SHUT DOWN. ANOTHER LOOK SHOWED A DISSECTION OCCURRED. THE DISSECTION WAS TREATED WITH A STENT AND RUN OFF WAS RESTORED. PT HAD GOOD OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES INC. PV31300 100118

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention