BEUDAMED
    FDA Adverse Event Other Summary report: N

    JETSTREAM NAVITUS

    MDR report key: 3037841 · Received April 2, 2013

    Report

    Report Number
    2183460-2013-00005
    Event Type
    Other
    Date Received
    April 2, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 8, 2013
    Manufacturer
    BAYER INTERVENTIONAL
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF A JETSTREAM DEVICE GETTING STUCK ON A GUIDEWIRE RESULTING IN LOSS OF GUIDEWIRE POSITION. THE PATIENT GENDER, AGE AND MEDICAL HISTORY ARE UNKNOWN. THE PHYSICIAN GAINED ACCESS VIA A RIGHT ANTEGRADE STICK TO THE 4-6 MM SUPERFICIAL FEMORAL ARTERY (SFA) ALL THE WAY TO THE POPLITEAL USING A 0.014 SPARTACORE (ABBOTT VASCULAR) GUIDEWIRE. THE PHYSICIAN PLACED A 7FR SHEATH AND DECIDED TO BALLOON AND STENT THE MID AND DISTAL SFA. ON THE WAY OUT TO COMPLETE THE CASE THE PHYSICIAN NOTICED AN ECCENTRIC CALCIFIED LESION PROXIMAL SFA ABOUT 2-5 CM BELOW THE TIP OF THE SHEATH. THE PHYSICIAN THEN USED A JETSTREAM NAVITUS ATHERECTOMY CATHETER. WHEN THE TECHNICIAN TURNED ON THE NAVITUS DEVICE WHILE THE PHYSICIAN MOVED THE DEVICE FORWARD THE JETSTREAM CONSOLE RPM'S RAMPED DOWN. THE PHYSICIAN THEN MOVED THE NAVITUS DEVICE BACK AND THEN TRIED TO MOVE BACK AGAIN WHEN THEN THE NAVITUS DEVICE MADE A NOISE AND A COUPLE CLICKING SOUNDS. THE PHYSICIAN COULD NOT REX THE NAVITUS DEVICE OUT AND DETERMINED IT WAS STUCK ON THE GUIDEWIRE. THE PHYSICIAN HAD TO PULL THE NAVITUS DEVICE AND GUIDEWIRE OUT AT THE SAME TIME WHICH MEANT GUIDEWIRE POSITIONING WAS LOST. THE PHYSICIAN STATED THAT THIS POINT THEY TOOK A PICTURE OF THE PROXIMAL SFA AND NOTICED THE VESSEL WAS SPASMED DOWN SO NITROGLYCERIN WAS GIVEN. THE PHYSICIAN THEN RE-RAN THE LESION WITH A GUIDEWIRE AND THEN BALLOON AND STENTED THE ECCENTRIC CALCIFIED LESION. THE PHYSICIAN STATED THE PATIENT WAS FINE. 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 CAE, THE SPARTACORE GUIDEWIRE IS LISTED IN THE NAVITUS IFU AS A RECOMMENDED COMPATIBLE GUIDEWIRE. THIS EVENT IS CONSIDERED A REPORTABLE EVENT SINCE THE STICKING OF THE JETSTREAM NAVITUS DEVICE AND SPARTACORE GUIDEWIRE RESULTED IN THE LOSS OF GUIDEWIRE POSITION AND ALTERNATIVE BALLOON AND STENT THERAPY TO TREAT THE LESION. THE CUSTOMER SITE STATED THAT THEY WENT IN WITH THE NAVITUS CATHETER AND WHEN THE TECH TURNED ON THE DEVICE THE PHYSICIAN MOVED FORWARD AND THE CONSOLE REPM'S RAMPED DOWN SO THE PHYSICIAN BACKED UP AND THEN WENT BACK AGAIN AND IT MADE A NOISE AND A COUPLE OF CLICKING SOUND. THEY COULD NOT REX IT OUT AND IT WAS STUCK ON THE WIRE. INSPECTED THE RETURNED NAVITUS JETSTREAM CATHETER AND OBSERVED A GUIDEWIRE STICK 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 WORKING, ATTEMPTED TO REX GUIDEWIRE OUT OF CATHETER AND GUIDEWIRE WOULD NOT MOVE. THE WELD AT THE TIP WAS SEPARATED TO INVESTIGATE THE BUSHING THAT FITS INSIDE. OBSERVED THAT THE BUSHING IS LOCKED UP ON THE GUIDEWIRE. A KINK IN THE GUIDEWIRE WAS ALSO NOTICED JUST PROXIMAL OF THE BUSHING. DUET 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

    THIS WAS A RIGHT ANTEGRADE STICK ON A SFA W/DISEASE (DIFFUSE) ALL THE WAY TO THE POPLITEAL AREA. THE PHYSICIAN PLACED A 7FR SHEATH AND DECIDED TO BALLOON AND STENT THE MID AND DISTAL SFA. ON THE WAY OUT TO WRAP UP THE CASE HE NOTICED A ECCENTRIC CALCIUM LESION PROX SFA ABOUT 2-5 CM'S BELOW THE TIP OF THE SHEATH. HE THEN WENT IN WITH THE NAVITUS CATHETER AND WHEN THE TECH TURNED ON THE DEVICE THE PHYSICIAN MOVED FORWARD AND THE CONSOLE RPM'S RAMPED DOWN SO THE PHYSICIAN BACKED UP AND THEN WENT BACK AGAIN AND IT MADE A NOISE AND A COUPLE OF CLICKING SOUNDS. THEY COULD NOT REX IT OUT AND IT WAS STUCK ON THE WIRE. THEY HAD TO PULL THE DEVICE AND WIRE OUT WHICH MEANS THEY LOST WIRE PLACEMENT. DR (B)(6) SAID AT THIS POINT WHEN THEY TOOK THE PICTURE THAT THE PROX SFA WAS SPASMED DOWN SO THEY GAVE NITRO. THEY THEN HAD TO RE-RUN THE LESION AND HE SAID THEY THEN BALLOONED AND STENTED THAT AREA AND PATIENT WAS FINE. THOUGHTS: WITHOUT IVUS IT WOULD BE HARD TO SAY BUT DR (B)(6 WAS WONDERING IF MAYBE THERE WAS A FLAP OF THE LUMEN THAT THE CUTTER WRAPPED AROUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134368 JETSTREAM NAVITUS JETSTREAM NAVITUS MCW BAYER INTERVENTIONAL 030542-004 121107

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention