BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 2023566 · Received March 16, 2011

    Report

    Report Number
    3003603429-2011-00009
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 16, 2011
    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 RETURNED DEVICE WAS EVALUATED AND THE CAUSE OF THE JETSTREAM G3'S ISSUE WITH ASPIRATION WAS DUE TO TISSUE OCCLUDING THE ASPIRATION LUMEN. 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. THE DEVICE WAS NOT USED PER THE IFU. IT WAS REPORTED THAT THE RUN TIME FOR THE DEVICE WAS 10 MINUTES 30 SECONDS. THERE IS A NOTE IN THE IFU REGARDING RUN TIME: "THE JETSTREAM G3 CATHETER USE TIME SHOULD NOT EXCEED 10 MINUTES. MONITOR THE TIMER ON THE PV CONSOLE AND USE A SECOND DEVICE IF ADDITIONAL TREATMENT IS REQUIRED." ADDITIONALLY, IN-STENT RESTENOSIS PATIENTS ARE LISTED AS A SPECIAL PATIENT POPULATION (I.E., THE SAFETY AND EFFECTIVENESS OF THE JETSTREAM G3 SYSTEM HAS NOT BEEN ESTABLISHED IN THIS GROUP OF PATIENTS) IN THE IFU. LASTLY, THE GUIDEWIRE USED IN THIS CASE IS A EV3 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 AN APPROXIMATELY 1.5 CM IN-STENT RESTENOSIS (ISR) LESION LOCATED IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). A PASS WAS MADE USING THE MINIMUM DIAMETER MODE AND WAS AS EXPECTED FOR THE FIRST 3 MINUTES. SLOWING IN ASPIRATION WAS THEN NOTED. AFTER ANOTHER 1-2 MINUTES OF RUNTIME, ASPIRATION STOPPED. THE DEVICE WAS REMOVED AND RE-PRIMED WITH SUCCESS. THE DEVICE WAS REINSERTED AND CLOGGED AGAIN WITHIN 1-2 MINUTES OF RUNTIME USING MAXIMUM DIAMETER MODE. THE DEVICE WAS REMOVED AND ANOTHER JETSTREAM G3 UNIT WAS USED TO FINISH THE CASE. THE PATIENT'S ANTERIOR TIBIAL ARTERY WAS CLOSED OFF POST PROCEDURE. PTA WAS USED TO TREAT THE DISTAL EMBOLI WITH A GOOD RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES INC. PV31300 110125

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention