BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 2162092 · Received July 12, 2011

    Report

    Report Number
    3003603429-2011-00029
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    May 18, 2011
    Report Date
    July 12, 2011
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES INC.
    Product Code
    MCW
    PMA / PMN Number
    K110626
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATHWAY JETSTREAM G3 CATHETER WAS DISCARDED AFTER THE PROCEDURE AND THEREFORE, NOT RETURNED TO PATHWAY MEDICAL TECHNOLOGIES FOR EVALUATION. DISTAL EMBOLIZATION IS AN INHERENT RISK FOR THE TREATMENT OF PERIPHERAL VASCULAR DISEASE WITH PATHWAY MEDICAL'S JETSTREAM G3 SYSTEM AND IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE IFU. LASTLY, THE GUIDEWIRE USED IN THIS CASE IS A PLATINUM PLUS GUIDEWIRE WHICH IS NOT A COMPATIBLE ACCESSORY AND THE IFU INCLUDES A CAUTION REGARDING THE USE OF GUIDEWIRES NOT LISTED FOR USE, "USE ONLY LISTED COMPATIBLE GUIDEWIRES AND INTRODUCERS WITH THE JETSTREAM G3 SYSTEM. USE OF ANY SUPPLIES NOT LISTED AS COMPATIBLE MAY COMPROMISE PERFORMANCE OF OR DAMAGE THE JETSTREAM G3 SYSTEM."

    Description of Event or Problem · 1

    THE JETSTREAM G3 DEVICE WAS USED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) OF THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH AN AREA OF OCCLUSION PROXIMAL TO PREVIOUS PLACED STENTS IN THE MID TO DISTAL SFA. TWO PASSES WERE ATTEMPTED WITH CONSIDERED NORMAL OPERATION THROUGH THE DISEASED AREA. ASPIRATION APPEARED TO BE DIMINISHED AND COMPLETELY CEASED. THE DEVICE WAS THEN RETRACTED OUT FOR ANGIOGRAMS TO BE TAKEN. FLOW WAS SOMEWHAT BETTER BUT OUTFLOW WAS DIMINISHED DUE TO POSSIBLE SHOWERING OF EITHER CLOT OR EMBOLIC DEBRIS. PTA WAS THEN PERFORMED THROUGH THE AREA AND THROMBOTIC DEBRIS COULD BE VISUALIZED. A SECOND JETSTREAM WAS OPENED AND USED IN THE AREAS OF CONCERN, WITHOUT ANY ISSUES AND THERE WERE NO ASPIRATION ISSUES NOTED. ADDITIONAL PTA FOLLOWED AFTER THE SECOND JETSTREAM. PATIENT THEN UNDERWENT TREATMENT WITH A THROMBOLYTIC AGENT AND AN EMBOLECTOMY. THE NEXT MORNING, THERE WAS SOME RESTORATION OF FLOW AT THE LEVEL OF THE ANKLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES INC. PV31300 110505

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention