BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 2051296 · Received April 7, 2011

    Report

    Report Number
    3003603429-2011-00016
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 15, 2011
    Report Date
    April 7, 2011
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES, INC.
    Product Code
    MCW
    PMA / PMN Number
    K101221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 EVAL. DISTAL EMBOLIZATION AND DISSECTION ARE INHERENT RISKS FOR THE TREATMENT OF PERIPHERAL VASCULAR DISEASE WITH PATHWAY MEDICAL'S JETSTREAM G3 SYSTEM AND ARE LISTED AS POTENTIAL ADVERSE EVENTS IN THE IFU. IT WAS REPORTED THAT THE RUN TIME FOR THE DEVICE WAS 12 MINS. THERE IS A NOTE IN THE IFU REGARDING RUN TIME: "THE JETSTREAM G3 CATHETER USE TIME SHOULD NOT EXCEED 10 MINS. MONITOR THE TIMER ON THE PV CONSOLE AND USE A SECOND DEVICE IF ADD'L TREATMENT IS REQUIRED." LASTLY, IT WAS MENTIONED THAT THE DEVICE MIGHT HAVE BEEN USED SUBINTIMALLY. THE FOLLOWING STEP FROM THE PROCEDURE SECTION OF THE IFU INDICATES THE REQUIREMENT THAT THE GUIDEWIRE IS PLACED IN THE CENTRAL LUMEN (AND NOT SUBINTIMAL) TO ENSURE PROPER FUNCTION AND SAFE USE OF THE DEVICE: "STEP 5: VERIFY THAT THE GUIDEWIRE IS IN THE CENTRAL LUMEN OF THE VESSEL AND IS NOT SUBINTIMAL."

    Description of Event or Problem · 1

    THE JETSTREAM G3 WAS ADVANCED TO TREAT A SEVERELY CALCIFIED 30 CM LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE TREATED 10 CM OF THE LESION IN 12 MINUTES WHEN THE DEVICE BECAME STUCK ON THE GUIDEWIRE OR WAS POTENTIALLY SUBINTIMAL. STENTS WERE PLACED IN THE DISTAL SFA TO TREAT THE DISSECTIONS. AFTER THE FINAL RUN, THE PHYSICIAN NOTICED DISTAL EMBOLIZATION IN THE ANTERIOR TIBIAL WHICH WAS SUCCESSFULLY TREATED AND RESOLVED WITH A TISSUE PLASMINOGEN ACTIVATOR. THE PT WAS DOING WELL THE NEXT DAY. IT WAS UNDETERMINED IF THE DISTAL EMBOLI WAS CAUSED BY THE JETSTREAM G3 DEVICE OR ANOTHER MFR'S ATHERECTOMY DEVICE THAT WAS ATTEMPTED BEFORE USING THE JETSTREAM G3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES, INC. PV31300 101124

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention