BEUDAMED
    FDA Adverse Event Other Summary report: N

    JETSTREAM NAVITUS

    MDR report key: 2845008 · Received November 13, 2012

    Report

    Report Number
    2183460-2012-00021
    Event Type
    Other
    Date Received
    November 13, 2012
    Date of Event
    October 16, 2012
    Report Date
    November 13, 2012
    Manufacturer
    BAYER INTERVENTIONAL, INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF A JETSTREAM DEVICE FAILURE RESULTING IN A DISTAL EMBOLIZATION DURING A JETSTREAM PROCEDURE. THE PATIENT IS A FEMALE OF UNKNOWN AGE AND MEDICAL HISTORY. THE PHYSICIAN WAS USING A JETSTREAM NAVITUS ATHERECTOMY CATHETER TO TREAT A CALCIFIED DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE NAVITUS DEVICE WOULD NOT ADVANCE THROUGH 4CM OF CALCIUM. DURING THE PROCEDURE, THE NAVITUS DEVICE ADVANCED APPROXIMATELY 2CM AND STALLED. AN ANGIOGRAM WAS PERFORMED AND DURING THIS TIME, THE NAVITUS DEVICE RELEASED A PIECE OF DISTAL EMBOLI INTO THE TIBIOPERONEAL (TP) TRUNK. AT THIS TIME, THE PATIENT IMMEDIATELY COMPLAINED OF FOOT PAIN. THE PHYSICIAN USED A JETSTREAM G3 SF ATHERECTOMY CATHETER IN A 3MM TP TRUNK AND WAS ABLE TO ASPIRATE THE DISTAL EMBOLI AND FLOW WAS RESTORED. ONCE THE FLOW WAS RESTORED WITH THE JETSTREAM G3 SF DEVICE, THE PATIENT'S PAIN IN THE FOOT WENT AWAY. THIS EVENT IS REPORTABLE SINCE THE PATIENT REQUIRED INTERVENTION CONSISTING OF ADDITIONAL JETSTREAM TREATMENT AS A RESULT OF THE DISTAL EMBOLIZATION AND THE ASSOCIATION BETWEEN THE JETSTREAM DEVICE AND THE NOTED EVEN CANNOT BE CONCLUSIVELY RULED OUT.

    Description of Event or Problem · 1

    PLEASE REPLACE A 1.85 G3 SF TO THE ACCOUNT AT NO CHARGE TO THE HOSPITAL. ATTENTION: (B)(6). USED NAVITUS TO TREAT CALCIFIED DISTAL SFA. THE NAVITUS WOULD NOT ADVANCE THROUGH 4CM OF CALCIUM. NAVITUS WENT ABOUT 2CM AND STALLED. WHEN WE SHOT AN ANGIOGRAM THE NAVITUS SENT A PIECE OF DISTAL EMBOLI INTO THE TP TRUNK. THANKFULLY, THE ACCOUNT HAD 1.85 G3SF THAT WE USED IN A 3MM TP TRUNK. THE G3SF WAS ABLE TO ASPIRATE THE DISTAL EMBOLI AND FLOW WAS RESTORED. WHEN WE SHOT DISTAL EMBOLI, THE PATIENT IMMEDIATELY COMPLAINED OF FOOT PAIN. ONCE WE RESTORED FLOW WITH THE G3, THE PATIENT'S PAIN WENT AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM NAVITUS JETSTREAM NAVITUS MCW BAYER INTERVENTIONAL, INC. 030542-004 120410

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention