BEUDAMED
    FDA Adverse Event Other Summary report: N

    JETSTREAM NAVITUS L

    MDR report key: 2885356 · Received December 19, 2012

    Report

    Report Number
    2183460-2012-00024
    Event Type
    Other
    Date Received
    December 19, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 19, 2012
    Manufacturer
    BAYER INTERVENTIONAL, INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF A JETSTREAM DEVICE FAILURE RESULTING IN AN ALLEGED DISTAL EMBOLIZATION DURING A JETSTREAM PROCEDURE. THE PATIENT'S AGE, GENDER, AND MEDICAL HISTORY ARE UNKNOWN. THE PATIENT PRESENTED WITH A CALCIFIED AND THROMBOSED LESION 200MM IN LENGTH IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN WAS TREATING THE SFA LESION WITH A JETSTREAM NAVITUS L ATHERECTOMY CATHETER WHEN APPROXIMATELY 4 MINUTES INTO USE THE NAVITUS L DEVICE QUIT ASPIRATION. THE PHYSICIAN REMOVED THE NAVITUS L DEVICE AND IT WAS THEN NOTICED WHAT APPEARED TO BE A DISTAL EMBOLIZATION IN THE TIBIAL VESSEL. THE PHYSICIAN USED A NEW NAVITUS L DEVICE TO TREAT THE SFA LESION. IN ADDITION, THE PHYSICIAN USED A MEDRAD FETCH 2 ASPIRATION CATHETER TO TREAT THE DISTAL EMBOLIZATION THE TIBIAL VESSEL. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS FROM THE PROCEDURE AND WAS SENT HOME THE SAME DAY. THIS EVENT IS REPORTABLE SINCE THE PATIENT REQUIRED INTERVENTION CONSISTING OF MANUAL ASPIRATION WITH THE FETCH 2 DEVICE AS A RESULT OF THE DISTAL EMBOLIZATION AND THE ASSOCIATION BETWEEN THE JETSTREAM NAVITUS L DEVICE AND THE NOTED EVENT CANNOT BE CONCLUSIVELY RULED OUT.

    Description of Event or Problem · 1

    REP RECEIVED CALL THAT CATHETER APPEARED TO BE NOT ASPIRATING, ADVISED TO WITHDRAW AND FLUSH AND REPLACE IF IT CONTINUES. ACCOUNT SAYS DEVICE NEVER REGAINED ASPIRATION. DEVICE WAS NOT SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM NAVITUS L JETSTREAM NAVITUS L MCW BAYER INTERVENTIONAL, INC. 031005-001 121008

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention