BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 1696070 · Received May 20, 2010

    Report

    Report Number
    3003603429-2010-00017
    Event Type
    Injury
    Date Received
    May 20, 2010
    Date of Event
    April 20, 2010
    Report Date
    May 20, 2010
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES INC.
    Product Code
    MCW
    PMA / PMN Number
    K093456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE G3 DEVICE DID NOT APPEAR TO BE ASPIRATING PROPERLY SINCE ONLY CLEAR FLUID WAS IN THE ASPIRATION BAG. WHILE THE DEVICE WAS NOT ASPIRATING PROPERLY, PLAQUE AND THROMBUS MOVED DISTALLY AND THE PERONEAL ARTERY SHUT DOWN. ANOTHER MFR'S ASPIRATION CATHETER AND ANGIOPLASTY WERE USED IN THE SFA AS WELL AS BELOW THE KNEE TO MAINTAIN A SINGLE VESSEL RUNOFF OUT OF TWO. PT WAS DISCHARGED AND IS DOING OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECOTMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES INC. PV31300 100319

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention