BEUDAMED
    FDA Adverse Event Other Summary report: N

    JETSTREAM G3 SF

    MDR report key: 2640606 · Received June 21, 2012

    Report

    Report Number
    2183460-2012-00010
    Event Type
    Other
    Date Received
    June 21, 2012
    Date of Event
    May 25, 2012
    Report Date
    June 21, 2012
    Manufacturer
    BAYER INTERVENTIONAL, INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF VESSEL PERFORATION DURING A JETSTREAM PROCEDURE. THE PT IS A (B)(6) MALE WITH UNKNOWN MEDICAL HISTORY. THE PT PRESENTED WITH A TOTAL OCCLUSION (LESION) OF THE RIGHT ANTERIOR TIBIAL (AT) ARTERY. A 0.035" STRAIGHT ANGLED GLIDEWIRE WAS INSERTED THROUGH LESION IN RIGHT AT. ONCE THE LESION WAS SUCCESSFULLY CROSSED, THE 0.035" WIRE WAS EXCHANGED FOR A 0.014" GRANDSLAM GUIDEWIRE. THE ARTERY DIAMETER MEASURED 2.5 MM OR GREATER AT MULTIPLE POINTS PROXIMAL, DISTAL, AND INSIDE THE OCCLUSION. THE ARTERY LESION MEASURED APPROXIMATELY 5-6 CM LONG. A JETSTREAM G3SF 1.85 MM ATHERECTOMY CATHETER WAS PREPPED AND DELIVERED PROXIMAL TO THE LESION. THE JETSTREAM DEVICE WAS OPERATED THROUGH APPROXIMATELY 2 CM OF THE LESION AT A PRESCRIBED RATE OF 1 MM/SECOND. APPROXIMATELY MIDWAY THROUGH THE LESION THE JETSTREAM DEVICE STALLED. THE PHYSICIAN REVERSED THE JETSTREAM DEVICE TO TRY TO RE-ATTEMPT TO CROSS THE STALLED POINT; HOWEVER, THE DEVICE STALLED AGAIN. THE PHYSICIAN THEN REMOVED THE JETSTREAM DEVICE FROM THE PT USING PROPER TECHNIQUE AND GUIDEWIRE MANAGEMENT. THE PHYSICIAN THEN PERFORMED AN ARTERIOGRAM AND DISCOVERED THAT THERE WAS A PERFORATION IN THE LATERAL WALL OF THE AT AS SHOWN BY BLOOD EXTRAVASATION. THE PHYSICIAN ATTEMPTED TWO BALLOON INFLATIONS WITH A 2 MM X 20 MM POWER CROSS PTA BALLOON. THESE BALLOON INFLATIONS ALSO ACHIEVED REVASCULARIZATION OF THE DISTAL PORTION OF THE OCCLUSION. A SUBSEQUENT ARTERIOGRAM SHOWED CONTINUED EXTRAVASATION OF BLOOD. THE PHYSICIAN THEN INSERTED AND DEPLOYED A 3 MM X 16 MM COVERED JOSTENT ACROSS THE PERFORATED PORTION OF THE AT. AN ARTERIOGRAM WAS PERFORMED AND SHOWED NO FURTHER EXTRAVASATION. THE PHYSICIAN PERFORMED ADDITIONAL ARTERIOGRAM TO SHOW THAT BLOOD FLOW WAS FULLY RESTORED INTO THE FOOT. THE IFU HAS THE FOLLOWING CAUTION STATEMENTS: "USE ONLY LISTED COMPATIBLE GUIDEWIRES AND INTRODUCERS WITH THE JETSTREAM G3 SF SYSTEM. USE OF ANY SUPPLIED NOT LISTED AS COMPATIBLE MAY COMPROMISE PERFORMANCE OF OR DAMAGE THE JETSTREAM G3 SF SYSTEM." "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 PT. ABSENCE OF THE GUIDEWIRE MAY LEAD TO INABILITY TO STEER THE CATHETER AND CAUSE POTENTIAL VESSEL DAMAGE." "DO NOT MANIPULATE THE CATHETER AGAINST RESISTANCE UNLESS THE CAUSE FOR RESISTANCE HAS BEEN DETERMINED. DAMAGE TO THE VESSEL OR DEVICE MAY OCCUR." "IF THE GUIDEWIRE IS ACCIDENTALLY RETRACTED INTO THE DEVICE DURING PLACEMENT OR TREATMENT, STOP USE, AND REMOVE THE CATHETER AND THE GUIDEWIRE FROM THE PT. 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." 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

    PHYSICIAN ATTEMPTED REVASCULARIZATION OF A TOTAL OCCLUSION IN PT'S RIGHT ANTERIOR TIBIAL (AT) ARTERY. A 0.035" STRAIGHT ANGLED GLIDEWIRE WAS INSERTED THROUGH LESION IN RIGHT AT. ONCE SUCCESSFULLY CROSSED, WIRE WAS EXCHANGED FOR A 0.014" GRANDSLAM GUIDEWIRE. ARTERY DIAMETER MEASURED AT 2.5 MM OR GREATER AT MULTIPLE POINTS PROXIMAL, DISTAL AND INSIDE OF THE OCCLUSION. LESION MEASURED APPROXIMATELY 5-6 CM LONG. PHYSICIAN REQUESTED A JETSTREAM G3SF 1.85 MM CATHETER TO BE USED TO DEBULK THE TOTAL OCCLUSION. G3SF 1.85 MM CATHETER WAS PREPPED AND DELIVERED TO PROXIMAL TO LESION (TOTAL OCCLUSION). G3SF CATHETER OPERATED THROUGH APPROXIMATELY 2 CM OF LESION AT A PROPER RATE (1 MM/SECOND). APPROXIMATELY MIDWAY THROUGH LESION, G3SF STALLED. PHYSICIAN REVERSED THE DEVICE TO RE-ATTEMPT TO CROSS STALLED POINT; AGAIN DEVICE STALLED; G3SF WAS THEN REMOVED USING PROPER TECHNIQUE AND GUIDEWIRE MANAGEMENT. ARTERIOGRAM WAS PERFORMED AND IT WAS DISCOVERED THAT THERE WAS PERFORATION IN THE LATERAL WALL OF AT PROVEN BY BLOOD EXTRAVASATION. PHYSICIAN ATTEMPTED TWO BALLOON INFLATIONS WITH A 2 MM X 20 MM POWER CROSS PTA BALLOON. THESE BALLOON INFLATIONS ALSO ACHIEVED REVASCULARIZATION OF DISTAL PORTION OF OCCLUSION. A SUBSEQUENT ARTERIOGRAM SHOWED CONTINUED EXTRAVASATION OF BLOOD. PHYSICIAN THEN INSERTED AND DEPLOYED A 3 MM X 16 MM COVERED JOSTENT ACROSS PERFORATED PORTION OF AT. ARTERIOGRAM WAS PERFORMED AND SHOWED NO FURTHER EXTRAVASATION. PHYSICIAN PERFORMED ADDITIONAL ARTERIOGRAM TO SHOW THAT BLOODFLOW WAS FULLY RESTORED INTO THE FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 SF JETSTREAM G3 SF MCW BAYER INTERVENTIONAL, INC. JETSTREAM G3 SF 1.85 120103

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention