BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 1641376 · Received March 24, 2010

    Report

    Report Number
    3003603429-2010-00006
    Event Type
    Injury
    Date Received
    March 24, 2010
    Date of Event
    February 3, 2010
    Report Date
    March 24, 2010
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES INC.
    Product Code
    MCW
    PMA / PMN Number
    K093456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATHWAY JETSTREAM G3 CATHETER WAS RETURNED TO PATHWAY MEDICAL TECHNOLOGIES FOR EVAL. THE GUIDEWIRE WAS RETURNED IN THE DEVICE. THE GUIDEWIRE WAS BROKEN AT THE LOCATION WHERE THE SPRING TIP IS BONDED TO THE CORE OF THE GUIDEWIRE. THE DETACHED TIP OF THE GUIDEWIRE WAS NOT RETURNED AND IT COULD NOT BE DETERMINED WHETHER THE JETSTREAM G3 DEVICE CAUSED THE GUIDEWIRE BREAK. IT IS UNK WHETHER THE GUIDEWIRE BREAK WAS DUE TO INTERACTION WITH THE JETSTREAM G3 DEVICE. IT WAS NOTED THAT THE GUIDEWIRE WAS LIKELY SUBINTIMAL, WHICH IS NOT PER THE IFU. THE IFU INCLUDES INFO TO VERIFY GUIDEWIRE PLACEMENT IN THE CENTRAL LUMEN AND IS NOT SUBINTIMAL.

    Description of Event or Problem · 1

    THE JETSTREAM G3, WAS ADVANCED TO TREAT THE ENTIRE SFA WHICH WAS A CHRONIC TOTAL OCCLUSION (CTO) WITH HEAVY CALCIUM PRESENT. THE DEVICE WAS INSERTED AND RAN IN THE MINIMUM DIAMETER MODE DURING THE FIRST PASS. THE DEVICE GOT TO THE DISTAL SFA/POPLITEAL AND ENCOUNTERED RESISTANCE. AS THE DEVICE WAS BEING REMOVED USING RETRACTION MODE, IT BECAME STUCK ON THE GUIDEWIRE. PART OF THE GUIDEWIRE WAS ALSO NOTED TO HAVE BROKEN OFF. THE DETACHED PORTION OF THE GUIDEWIRE WAS THEN SUCCESSFULLY SNARED AND THE CASE WAS FINISHED WITH A BALLOON AND STENT WITH A GOOD OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES INC. PV31300 091230

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention