BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 1629983 · Received March 11, 2010

    Report

    Report Number
    3003603429-2010-00003
    Event Type
    Injury
    Date Received
    March 11, 2010
    Date of Event
    February 9, 2010
    Report Date
    March 11, 2010
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES INC.
    Product Code
    MCW
    PMA / PMN Number
    K092332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 DEVICE WAS USED TO TREAT A 30CM LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL. THE CASE WAS UNUSUALLY LONG AND THE LESIONS TREATED WERE VERY LONG AND THROMBOTIC AND THE DEVICE HAD MANY (> 20) MINUTES OF OPERATION. THE DEVICE ALSO SAT ON THE TABLE FOR OVER AN HOUR AT ONE POINT AND 30 MINUTES AT ANOTHER POINT OVER THE CASE DURATION. THEREFORE, WHEN THE DEVICE WAS RE-INTRODUCED INTO THE BODY THE SECOND TIME, THERE WAS GUIDEWIRE STICK. AT ONE POINT, IT TOOK QUITE A BIT OF FORCE TO ADVANCE THE DEVICE OVER THE GUIDEWIRE AND THE DEVICE JUMPED A BIT AND SUCKED PART OF THE TIP OF THE GUIDEWIRE BACK INTO THE CATHETER. IT WAS LATER NOTICED THAT THE DISTAL TIP OF THE GUIDEWIRE HAD BEEN DETACHED DOWN INTO THE PERONEAL ARTERY. THE PERONEAL ARTERY WAS PREVIOUSLY OCCLUDED AND THE PHYSICIAN SAID IT WASN'T A BIG ISSUE. THE GUIDEWIRE IS STILL IN THE PERONEAL ARTERY BUT NO FURTHER DAMAGE WAS DONE TO THE ARTERY. THE PATIENT WAS RELIEVED OF HER SYMPTOMS AND WENT HOME SHORTLY AFTER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention