BEUDAMED
    FDA Adverse Event Other Summary report: N

    JETSTREAM NAVITUS

    MDR report key: 3004171 · Received March 12, 2013

    Report

    Report Number
    2183460-2013-00001
    Event Type
    Other
    Date Received
    March 12, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 18, 2013
    Manufacturer
    BAYER INTERVENTIONAL
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF A JETSTREAM DEVICE GETTING STUCK ON A FILER WIRE ALLEGEDLY RESULTING IN A DISTAL EMBOLIZATION DURING A JETSTREAM PROCEDURE. THE PT GENDER AND AGE ARE UNK. THE PT'S MEDICAL HISTORY IS ALSO UNK WITH THE EXCEPTION OF A PREVIOUSLY PLACED STENT. THE PT PRESENTED WITH IN-STENT RESTENOSIS (ISR) IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN PLACE A COVIDIEN SPIDERFX EMBOLIC PROTECTION DEVICE (SPIDER FILTER WIRE) PRIOR TO JETSTREAM THERAPY. DURING THE PROCEDURE THE PHYSICIAN USED A JETSTREAM NAVITUS ATHERECTOMY CATHETER WHICH BECAME STUCK ON THE SPIDER FILTER WIRE DURING REX AND REMOVAL OF THE JETSTREAM DEVICE. THE JETSTREAM DEVICE AND SPIDER FILTER WIRE HAD TO BE REMOVED TOGETHER WHICH CAUSED SOME DISTAL EMBOLIZATION ACCORDING TO THE PHYSICIAN. THE EMBOLIZATION WAS CLEARED WITH NITROGLYCERIN (NTG) AND ASPIRATION CATHETERS AND NO ADD'L INTERVENTION WAS NEEDED. THE PHYSICIAN STATED THE PT WAS FINE AT THE END OF THE CASE AND HAD GOOD RESULT FROM THE JETSTREAM CATHETER. THE JETSTREAM NAVITUS INSTRUCTIONS FOR USE (IFU) CAUTIONS AND NOTES 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 SPIDER FILTER WIRE IS NOT LISTED IN THE JETSTREAM NAVITUS IFU AS A COMPATIBLE DEVICE. THE JETSTREAM NAVITUS DEVICE WAS NOT ADVERSELY AFFECTED DURING ATHERECTOMY BUT THE INCOMPATIBILITY OF THE DEVICES MAY HAVE CONTRIBUTED TO THE STICKING OF THE SPIDER FILTER WIRE TO THE NAVITUS DEVICE WHICH PROHIBITED THE LONE REMOVAL OF THE NAVITUS DEVICE. INSPECTED THE RETURNED NAVITUS JETSTREAM CATHETER AND OBSERVED A GUIDEWIRE STUCK INSIDE THE CATHETER, WAS NOT ABLE TO REMOVE GUIDEWIRE FROM CATHETER. OPERATED THE CATHETER WITH A KNOWN GOOD JETSTREAM CONSOLE, ALL MODES OF THE CATHETER WORKED, ATTEMPTED TO REX GUIDEWIRE OUT OF CATHETER AND GUIDEWIRE WOULD NOT MOVE. SEPARATED THE WELD AT THE TIP TO BE ABLE TO INVESTIGATE THE GUIDEWIRE BUSHING THAT SITS INSIDE THE TIP. OBSERVED THAT THE BUSHING IS LOCKED UP ON THE GUIDEWIRE. ALSO NOTICED A KINK IN THE GUIDEWIRE JUST PROXIMAL OF THE BUSHING. DUE TO THE GUIDEWIRE LOCKING UP ON THE GUIDEWIRE BUSHING THE CUSTOMER SITE WOULD HAVE LOST FREE MOVEMENT OF THE GUIDEWIRE.

    Description of Event or Problem · 1

    DEVICE WAS USED FOR ISR CASE WITH A SPIDER FILTER. THE DEVICE STUCK ON FILTER WIRE DURING REX ON REMOVAL OF DEVICE. DEVICE AND SPYDER FILTER HAD TO BE REMOVED TOGETHER AND THE PHYSICIAN STATED THIS CAUSED SOME DISTAL EMBOLIZATION. THE EMBOLIZATION WAS CLEARED WITH NTG AND ASPIRATION CATHETERS AND NO ADD'L INTERVENTION WAS NEEDED. THE PHYSICIAN STATED THAT THE PT WAS FINE AT THE END OF THE CASE AND HAD A GOOD RESULT FROM THE JETSTREAM CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103687 JETSTREAM NAVITUS JETSTREAM NAVITUS MCW BAYER INTERVENTIONAL 030542-004 121023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention