BEUDAMED
    FDA Adverse Event Other Summary report: N

    JETSTREAM NAVITUS L

    MDR report key: 3034527 · Received March 29, 2013

    Report

    Report Number
    2183460-2013-00003
    Event Type
    Other
    Date Received
    March 29, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BAYER INTERVENTIONAL
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF A VESSEL PERFORATION DURING A JETSTREAM PROCEDURE. THE PATIENT IS (B)(6) MALE WITH PERIPHERAL ARTERY DISEASE (PAD) IN THE LEFT LEG. THE PATIENT PRESENTED WITH A 8CM MODERATE FIBROTIC LESION IN THE 3.5 MM DIAMETER MID-POPLITEAL ARTERY. A JETSTREAM NAVITUS L ATHERECTOMY CATHETER WAS PLACED THROUGH A 7 FR INTRODUCER AND OVER A 0.014 GUIDEWIRE AND ADVANCED TO THE POPLITEAL ARTERY. DURING THE PROCEDURE A PERFORATION OF THE POPLITEAL ARTERY WAS NOTICED. THE JETSTREAM DEVICE BOGGED DOWN AND REX DID NOT WORK TO BACK OUT THE DEVICE. THE PHYSICIAN ALSO COULD NOT GET THE DEVICE TO GOT WITH BLADES UP. THE JETSTREAM DEVICE WAS REMOVED AND A 5-0 X80 BALLOON WAS INFLATED TO COVER THE PERFORATION. THE PATIENT WAS SENT TO RECOVERY WHERE A BYPASS WAS PLANNED TO BYPASS THE POPLITEAL ARTERY. THE PATIENT RECEIVED A BYPASS OF THE POPLITEAL ARTERY WITH NICE OUTCOME POST PROCEDURE. THE IFU HAS THE FOLLOWING CAUTION STATEMENTS: "DO NOT MANIPULATE THE JETSTREAM NAVITUS L CATHETER AGAINST RESISTANCE UNLESS THE CAUSE FOR RESISTANCE HAS BEEN DETERMINED. DAMAGE TO THE VESSEL OR DEVICE MAY OCCUR. "USE ONLY LISTED COMPATIBLE GUIDEWIRES AND INTRODUCERS WITH THE JETSTREAM NAVITUS L SYSTEM. USE OF ANY SUPPLIES NOT LISTED AS COMPATIBLE MAY COMPROMISE PERFORMANCE OF OR DAMAGE THE JETSTREAM NAVITUS L SYSTEM." "DO NOT BEND OR KINK THE CATHETER DURING SETUP OR DURING THE PROCEDURE. THIS MAY DAMAGE THE DEVICE AND LEAD TO DEVICE FAILURE." "OPERATING THE CATHETER OVER A KINKED GUIDEWIRE MAY CAUSE VESSEL DAMAGE OR GUIDEWIRE FRACTURE." "DURING TREATMENT, DO NOT ALLOW CATHETER TIP WITHIN 10.0 CM OF SPRING TIP PORTION OF THE GUIDEWIRE. INTERACTION BETWEEN THE CATHETER TIP AND THIS PORTION OF THE GUIDEWIRE MAY CAUSE DAMAGE TO OR DETACHMENT OF THE GUIDEWIRE TIP OR COMPLICATE GUIDEWIRE MANAGEMENT." "THE GUIDEWIRE MUST BE IN PLACE PRIOR TO OPERATING THE CATHETER IN THE PATIENT. ABSENCE OF THE GUIDEWIRE MAY LEAD TO INABILITY TO STEER THE CATHETER AND CAUSE POTENTIAL VESSEL DAMAGE." "IF THE GUIDEWIRE IS ACCIDENTLY RETRACTED INTO THE DEVICE DURING PLACEMENT OR TREATMENT, STOP USE, AND REMOVE THE CATHETER AND THE GUIDEWIRE FROM THE PATIENT. VERIFY THAT THE GUIDEWIRE IS NOT DAMAGED BEFORE RE-INSERTING THE GUIDEWIRE. IF DAMAGE IS NOTICED, REPLACE THE GUIDEWIRE." "HOLD THE GUIDEWIRE FIRMLY DURING CATHETER RETRACTION PROCESS. FAILURE TO DO SO MAY RESULT IN GUIDEWIRE ROTATION WITHIN THE VESSEL." "DO NOT USE THE JETSTREAM NAVITUS L CATHETER IN MAXIMUM TIP DIAMETER (BLADES UP) UNLESS THE REFERENCE VESSEL DIAMETER IS > 4.5 MM. DOING SO MAY RESULT IN VESSEL DAMAGE. IN THIS CASE THE VESSEL DIAMETER OF THE MID POPLITEAL ARTERY WAS LISTED AS 3.5MM; HOWEVER, THE IFU RECOMMENDS A VESSEL DIAMETER OF > 4.5MM WHEN USING THE JETSTREAM DEVICE WITH BLADES UP. IT IS UNKNOWN IF THIS SMALLER THAN RECOMMENDED VESSEL SIZE CONTRIBUTED TO THE NOTED EVENT. THIS EVENT IS CONSIDERED REPORTABLE AS THE ASSOCIATION BETWEEN THE JETSTREAM DEVICE AND THE NOTED EVENT WHICH REQUIRED INTERVENTION CANNOT BE CONCLUSIVELY RULED OUT.

    Description of Event or Problem · 1

    PERFORATION OF POPLITEAL ARTERY. DEVICE BOGGED DOWN. REX DID NOT WORK ON BACK OF DEVICE. COULD NOT GET DEVICE TO GO BLADES UP. WILL CALL IN TOMORROW WHEN STAFF IS IN. UPDATE (B)(6) 2013: MALE (B)(6) CLAUDICANT LEFT LEG PAD. THIS HAPPENED AFTER DEVICE WAS PLACED OVER A .014 WIRE AND RUN IN THE POPLITEAL ARTERY. A PERFORATION WAS NOTED AND A BALLOON WAS INFLATED TO STOP THE PERFORATION. THE PATIENT WAS SENT TO RECOVERY WHERE A BYPASS WAS PLANNED TO BYPASS THE POPLITEAL ARTERY. BY PASS TO POPLITEAL NICE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131088 JETSTREAM NAVITUS L JETSTREAM NAVITUS L MCW BAYER INTERVENTIONAL 031005-001 121217

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention