BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3 SF

    MDR report key: 1870852 · Received October 7, 2010

    Report

    Report Number
    3003603429-2010-00043
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 8, 2010
    Report Date
    October 7, 2010
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES INC.
    Product Code
    MCW
    PMA / PMN Number
    K101334
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO INDICATION, BASED ON THE PHYSICAL EVAL OF THE RETURNED DEVICE AND THE REPORTED EVENT, THAT THE DEVICE FAILED TO PERFORM AS INTENDED (CAUSING A MALFUNCTION) LEADING TO THE DISSECTION. DISSECTION IS AN INHERENT RISK FOR THE TREATMENT OF PERIPHERAL VASCULAR DISEASE WITH PATHWAY MEDICAL'S JETSTREAM G3 SF SYSTEM AND IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE IFU. IT IS IMPORTANT TO NOTE THAT A SPIDER GUIDEWIRE WAS USED IN THIS CASE BUT IS NOT A COMPATIBLE ACCESSORY. 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 SF SYSTEM. USE OF ANY SUPPLIES NOT LISTED AS COMPATIBLE MAY COMPROMISE PERFORMANCE OF OR DAMAGE THE JETSTREAM G3 SF SYSTEM."

    Description of Event or Problem · 1

    THE JETSTREAM G3 SF WAS ADVANCED TO TREAT A THROMBOSED LESION LOCATED AT THE TIBIAL PERONEAL TRUNK AND BIFURCATION. A FEW PASSES WERE MADE DOWN THE POPLITEAL TO THE PERONEAL ARTERY. WHILE RETRACTING THE DEVICE TO TAKE AN ANGIOGRAM, THE DEVICE BECAME STUCK ON THE GUIDEWIRE. THE DEVICE AND GUIDEWIRE WERE REMOVED FROM THE PT AS ONE UNIT. AN ANGIOGRAM WAS PERFORMED AND REVEALED A DISSECTION. FOUR STENTS WERE PLACED TO TREAT THE DISSECTION. IT IS UNCERTAIN TO THE PHYSICIAN IF THE JETSTREAM G3 SF OR A GUIDEWIRE THAT WAS USED PREVIOUSLY CAUSED THE DISSECTION. THE PT IS OKAY AND HAS PULSES IN BOTH FEET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 SF PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES INC. PV3118F 100604

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention