BEUDAMED
    FDA Adverse Event Other Summary report: N

    JETSTREAM NAVITUS

    MDR report key: 2858076 · Received November 26, 2012

    Report

    Report Number
    2183460-2012-00022
    Event Type
    Other
    Date Received
    November 26, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 26, 2012
    Manufacturer
    BAYER INTERVENTIONAL, INC
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SITE STATED THAT WHEN REXING OUT TO TAKE ANGIOGRAM, NAVITUS DEVICE BECAME FROZEN TO THE WIRE. PHYSICIAN HAD TO PULL SPYDER WIRE OUT WITH THE NAVITUS. INSPECTED THE RETURNED JETSTREAM NAVITUS CATHETER AND NOTICED THE GUIDEWIRE WAS STUCK INSIDE THE CATHETER. OPERATED THE CATHETER WITH A KNOWN GOOD JETSTREAM CONSOLE. ATTEMPTED TO REX THE GUIDEWIRE OUT OF THE CATHETER, BUT THE GUIDEWIRE WAS STUCK. REMOVED THE TIP OF THE CATHETER AND DISCOVERED THAT THE SPYDER GUIDEWIRE WAS STUCK IN THE BUSHING INSIDE OF THE TIP. PULLED THE BUSHING OUT OF THE CATHETER AND THEN I WAS ABLE TO REMOVE THE GUIDEWIRE FROM THE CATHETER. INSPECTED THE BUSHING CLOSER AND NOTICED THAT THE COATING OF THE GUIDEWIRE HAS COME OFF AND IS STUFFING THE BUSHING, WHICH IMPEDES THE GUIDEWIRE FROM FREE MOVEMENT. REGULATORY ASSESSMENT: EVENT CONSISTS OF A JETSTREAM DEVICE FAILURE, WHICH MAY HAVE RESULTED IN A DISTAL EMBOLIZATION DURING A JETSTREAM PROCEDURE. THE PT IS A (B)(6) FEMALE WITH A MEDICAL HISTORY OF DIABETES, PREVIOUS ATHERECTOMY SEVEN MONTHS PRIOR, MIXED LESION MORPHOLOGY, AND SINGLE VESSEL RUNOFF BELOW THE KNEE. THE PT PRESENTED WITH A CLAUDICATION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN FIRST PLACED A SPYDER WIRE FILTER IN THE PERONEAL. THE PHYSICIAN THEN USED A JETSTREAM NAVITUS ATHERECTOMY CATHETER TO TREAT THE OCCLUDED SFA BY MAKING TWO PASSES WITH THE WINGS DOWN AND TWO PASSES WITH THE WINGS UP FOR A TOTAL RUN TIME OF 3.25 MINUTES. WHEN THE PHYSICIAN WAS REXING THE NAVITUS DEVICE OUT SO AN ANGIOGRAM COULD BE TAKEN, THE NAVITUS DEVICE BECAME FROZEN TO THE SPYDER WIRE. THE PHYSICIAN HAD TO PULL THE SPYDER WIRE OUT WITH THE NAVITUS CATHETER AS A SINGLE UNIT THROUGH THE 7F SHEATH. AFTER THE NAVITUS CATHETER WAS REMOVED, AN ANGIOGRAM WAS TAKEN. THE CLAUDICATION OF THE SFA WAS VERY HEAVY PRIOR TO TREATMENT WITH THE NAVITUS CATHETER, BUT WAS SUCCESSFULLY RESOLVED POST TREATMENT. IN ADDITION, IT WAS THEN NOTICED THE PT HAD AN OCCLUDED PROXIMAL DORALIS PEDIS (DP). THE PHYSICIAN USED AN ANGIOJET DISTA THROMBECTOMY SET IN ATTEMPT TO RESCUE THE DP, BUT THE PROCEDURE WAS UNSUCCESSFUL. THE PHYSICIAN DECIDED TO TAKE THE PT TO SURGERY TO PERFORM ENDARECTOMY OF THE DP. THE PHYSICIAN STATED THE OCCLUSION IN THE DP WAS FOUND AND REMOVED. THE PT WAS REPORTED TO BE DOING FINE WITH NO SUBSEQUENT SEQUELA. IN DISCUSSION WITH THE MEDRAD SALES REP, IT WAS STATED THE CAUSE OF THE OCCLUDED DP IS UNKNOWN AND IT IS POSSIBLE THAT THE OCCLUSION EXISTED PRIOR TO THE PROCEDURE; POSSIBLE DEBRIS FROM THE NAVITUS DEVICE OR SPYDER WIRE WOULD BE SPECULATIVE, AS IT IS UNKNOWN IF THE DP VESSEL WAS OCCLUDED PRIOR TO OR DURING THE PROCEDURE. 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 SPYDER WIRE FILTER IS NOT LISTED IN THE JETSTREAM NAVITUS IFU AS A COMPATIBLE DEVICE, THEREFORE, THIS POTENTIAL INCOMPATIBILITY MAY HAVE CONTRIBUTED TO THE NAVITUS DEVICE BECOMING FROZEN ON THE SPYDER WIRE. THIS EVENT IS REPORTABLE AS THE TIMING OF THE OCCLUDED DP IS UNKNOWN AND THE ASSOCIATION BETWEEN THE JETSTREAM AND NAVITUS DEVICE AND SUBSEQUENT IDENTIFICATION OF THE OCCLUDED DP CANNOT BE CONCLUSIVELY RULED OUT.

    Description of Event or Problem · 1

    CLAUDICATION OF RIGHT SFA, PREVIOUS ATHERECTOMY SEVEN MONTHS PRIOR. DIABETIC, MIXED LESION MORPHOLOGY, SINGLE VESSEL RUNOFF BELOW THE KNEE. USED SPYDER WIRE FILTER, PARKED IN PERONEAL. NAVITUS RUN TIME 3.25 MINUTES, TWO PASSES WINGS DOWN, AND TWO PASSES WINGS UP. WHEN REXING OUT TO TAKE ANGIOGRAM, NAVITUS DEVICE BECAME FROZEN TO THE WIRE. PHYSICIAN HAD TO PULL SPYDER WIRE OUT WITH THE NAVITUS CATHETER AS A SINGLE UNIT THOUGH THE 7F DESTINATION SHEATH. UPON EXIT, ANGIOGRAM WAS TAKEN. PT THEN PRESENTED WITH OCCLUDED PROXIMAL DP. ANJOJET DISTA CATHETER WAS USED TO RESCUE DORSALIS PEDUS (SP) WITH LITTLE EFFECT. PHYSICIAN DECIDED TO TAKE PT TO SURGERY TO PERFORM ENDARECTOMY OF DP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM NAVITUS JETSTREAM NAVITUS MCW BAYER INTERVENTIONAL, INC 030542-004 120216

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention