BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 2003847 · Received February 24, 2011

    Report

    Report Number
    3003603429-2011-00008
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 25, 2011
    Report Date
    February 24, 2011
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES, INC.
    Product Code
    MCW
    PMA / PMN Number
    K101221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED AND THE REPORTED ISSUE OF THE RPMS NOT DISPLAYING CORRECTLY, COULD NOT BE DUPLICATED OR CONFIRMED. THE DEVICE SPEED WAS DISPLAYED ON THE CONSOLE WHEN TESTED. IT IS UNCLEAR WHAT CAUSED THE DISSECTION. 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. LASTLY, THE GUIDEWIRE USED IN THIS CASE IS A SPIDER FILTER GUIDEWIRE WHICH IS NOT A COMPATIBLE ACCESSORY AND THE IFU INCLUDES A CAUTION REGARDING THE USE OF GUIDEWIRES NOT LISTED FOR USE, "USE ONLY LISTED COMPATIBLE GUIDEWIRES AND INTRODUCERS WITH THE JETSTREAM G3 SYSTEM. USE OF ANY SUPPLIES NOT LISTED AS COMPATIBLE MAY COMPROMISE PERFORMANCE OF OR DAMAGE THE JETSTREAM G3 SYSTEM."

    Description of Event or Problem · 1

    THE JETSTREAM G3 WAS ADVANCED TO TREAT A HIGHLY CALCIFIED LESION LOCATED IN THE POPLITEAL. THE DEVICE WAS PLACED OVER A SPIDER GUIDEWIRE AND TWO PASSES WERE MADE USING MINIMUM DIAMETER MODE. IT WAS THEN USED IN MAXIMUM DIAMETER MODE AND THE PATIENT EXPERIENCED PAIN. THE DEVICE WAS REMOVED AND AN ANGIOGRAM WAS TAKEN, WHERE A DISSECTION WAS NOTED. THE DISSECTION WAS SUCCESSFULLY TREATED WITH 3-0-45 MINUTES OF PTA. ONCE THE LESION WAS TREATED, THE PHYSICIAN TREATED A LESION WITH THE DEVICE IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA) OVER A GRAND SLAM GUIDEWIRE. THE LESION WAS TREATED USING ONE PASS IN THE MINIMUM DIAMETER MODE AND TWO PASSES IN THE MAXIMUM DIAMETER MODE. DURING THE LAST PASS IT WAS NOTICED BY THE PATHWAY SALES REP, THAT THE RPMS WERE NOT DISPLAYED ON THE CONSOLE. THE PHYSICIAN THEN REMOVED THE DEVICE BECAUSE HE FELT HE WAS FINISHED WITH THE ATHERECTOMY PORTION OF THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES, INC. PV31300 100922

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention