BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 2023562 · Received March 16, 2011

    Report

    Report Number
    3003603429-2011-00013
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 14, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED AND THE REPORTED ISSUE OF THE GUIDEWIRE BREAKING WAS DUE TO A KINK IN THE CATHETER. IT IS UNKNOWN WHAT CAUSED THE KINK IN THE CATHETER. AS NOTED IN THE IFU A POSSIBLE OUTCOME OF ALLOWING THE DEVICE TO BECOME KINKED IS A DEVICE FAILURE, "DO NOT BEND OR KINK THE CATHETER DURING SETUP OR DURING THE PROCEDURE. THIS MAY DAMAGE THE DEVICE AND LEAD TO DEVICE FAILURE." LASTLY, IT WAS REPORTED THAT THE RUN TIME FOR THE DEVICE WAS AROUND 12 MINUTES. 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, ISR IS LISTED AS A SPECIAL PATIENT POPULATION AND IS NOT INCLUDED IN THE INDICATIONS.

    Description of Event or Problem · 1

    THE JETSTREAM G3 WAS ADVANCED TO TREAT A LONG, DIFFUSE, IN-STENT RESTENOSIS (ISR) LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). ABOUT 25 CMS INTO THE LESION, THE DEVICE SEEMED TO LOSE ITS ABILITY TO ADVANCE. WHILE ATTEMPTING TO PULL THE DEVICE BACK THROUGH THE SHEATH, AN ABNORMAL AMOUNT OF FORCE SEEMED NECESSARY TO PULL IT OUT OF THE PATIENT. THE TECH GAVE AN UNUSUALLY STRONG TUG AND THE DEVICE AND PROXIMAL PORTION OF THE GUIDEWIRE CAME OUT, LEAVING APPROXIMATELY 100 CMS OF THE GUIDEWIRE IN THE PATIENT. THE PHYSICIAN WAS ABLE TO SNARE AND RETRIEVE THE REMAINING GUIDEWIRE OUT OF THE PATIENT. ANOTHER GUIDEWIRE AND DEVICE WERE OPENED AND USED TO FINISH 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 101210

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention