BEUDAMED
    FDA Adverse Event Other Summary report: N

    JETSTREAM NAVITUS

    MDR report key: 2748712 · Received September 12, 2012

    Report

    Report Number
    2183460-2012-00016
    Event Type
    Other
    Date Received
    September 12, 2012
    Date of Event
    August 1, 2012
    Report Date
    September 12, 2012
    Manufacturer
    BAYER INTERVENTIONAL, INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF A DISLODGED FILTER DURING A JETSTREAM PROCEDURE. THE PT AGE AND GENDER ARE UNK AS WELL AS ANY PT HISTORY WHICH IS ALSO UNK. THE PHYSICIAN WAS TREATING A CHRONICALLY OCCLUDED COMMON FEMORAL ARTERY/PROFUNDA SINCE THE SUPERFICIAL FEMORAL ARTERY WAS COMPLETELY GONE. THE PHYSICIAN WAS HOPING TO OPEN THE PROFUNDA WITH A JETSTREAM NAVITUS DEVICE OVER A SPIDERFX FILTER (COVIDIEN) PLACED IN THE MID-DISTAL PROFUNDA. DURING THE REMOVAL OF THE JETSTREAM DEVICE THE PHYSICIAN ENCOUNTERED SOME STICKING AND THE DISTAL END OF THE SPIDERFX FILTER DISLODGED FROM THE GUIDEWIRE AND REMAINS IN THE PROFUNDA. AT THE TIME OF THE PROCEDURE, THERE WAS RESTORED FLOW AROUND THE FILTER THROUGH THE PROFUNDA. THE JETSTREAM NAVITUS INSTRUCTIONS FOR USE (IFU) CAUTIONS THE USER. "DO NOT MANIPULATE THE JETSTREAM NAVITUS CATHETER AGAINST RESISTANCE UNLESS THE CAUSE FOR THAT RESISTANCE HAS BEEN DETERMINED. DAMAGE TO THE VESSEL OR DEVICE MAY OCCUR." "USE ONLY COMPATIBLE GUIDEWIRES AND INTRODUCERS WITH THE JETSTREAM NAVITUS SYSTEM. USE OF ANY SUPPLIES NOT LISTED AS COMPATIBLE MAY COMPROMISE PERFORMANCE OF OR DAMAGE THE JETSTREAM NAVITUS SYSTEM." IN THIS CASE THE SPIDERFX FILTER IS NOT LISTED IN THE JETSTREAM NAVITUS IFU AS A COMPATIBLE DEVICE. THE JETSTREAM NAVITUS DEVICE WAS NOT ADVERSELY AFFECTED BUT THE INCOMPATIBILITY OF THE DEVICE MAY HAVE CONTRIBUTED TO THE DISLODGEMENT OF THE SPIDERFX FILTER FROM THE GUIDEWIRE. THIS EVENT IS REPORTABLE SINCE THE ASSOCIATION BETWEEN THE JETSTREAM DEVICE AND THE NOTED DISLODGMENT OF THE FILTER FROM THE GUIDEWIRE EVENT CANNOT BE CONCLUSIVELY RULE OUT.

    Description of Event or Problem · 1

    I DON'T HAVE A LOT OF PRECISE DETAILS YET BUT I DID LEARN THAT DR. (B)(6) WAS TREATING A CHRONICALLY OCCLUDED CFA/PROFUNDA SINCE THE SFA WAS COMPLETELY GONE AND WAS HOPING TO OPEN THE PROFUNDA WITH NAVITUS DEVICE OVER A SPIDERFX PLACED IN THE MID-DISTAL PROFUNDA. DURING REMOVAL OF THE JETSTREAM, THE PHYSICIAN ENCOUNTERED SOME STICKING AND THE DISTAL END OF THE SPIDERFX FILTER DISLODGED FROM THE WIRE AND REMAINS IN THE PROFUNDA. AT THE TIME OF THE PROCEDURE, THERE WAS RESTORED FLOW AROUND THE FILTER THROUGH THE PROFUNDA BUT I DO NOT HAVE OTHER DETAILS AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other