BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 1637117 · Received March 19, 2010

    Report

    Report Number
    3003603429-2010-00004
    Event Type
    Injury
    Date Received
    March 19, 2010
    Date of Event
    February 19, 2010
    Report Date
    March 19, 2010
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES, INC.
    Product Code
    MCW
    PMA / PMN Number
    K093456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATHWAY JETSTREAM G3 CATHETER WAS RETURNED TO PATHWAY MEDICAL TECHNOLOGIES FOR EVALUATION. 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 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 DEVICE. THE IFU STATES THAT A POSSIBLE OUTCOME OF ALLOWING THE DEVICE TO COME IN CONTACT WITH THE TIP OF THE GUIDEWIRE IS DETACHMENT, "DURING TREATMENT, DO NOT ALLOW THE CATHETER TIP TO COME IN CONTACT WITH, OR RUN OVER, THE SPRING TIP PORTION OF THE GUIDEWIRE. CONTACT MAY CAUSE DETACHMENT OF THE GUIDEWIRE TIP". IT IS ALSO STATED IN THE IFU TO MANUALLY SECURE THE GUIDEWIRE DURING RETRACTION MODE AND ROTATION OF THE GUIDEWIRE DURING RETRACTION WOULD BE OBVIOUS TO THE PHYSICIAN.

    Description of Event or Problem · 1

    THE JETSTREAM G3 WAS ADVANCED TO TREAT A SEVERELY CALCIFIED 10CM LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE FIRST PASS WAS MADE IN MINIMUM DIAMETER MODE THROUGH THE DISTAL SFA LESION. THE PHYSICIAN ATTEMPTED TO RETRACT THE DEVICE AFTER THE FIRST PASS, USING RETRACTION MODE, AND ENCOUNTERED CONSIDERABLE RESISTANCE. AFTER CONTINUED ATTEMPT TO RETRACT THE CATHETER FROM THE LESION, THE GUIDEWIRE SNAPPED AND THE MOST DISTAL 10CM WAS LEFT IN THE POPLITEAL ARTERY. THE JETSTREAM G3 DEVICE WAS REMOVED AND THE DISTAL PORTION OF THE GUIDEWIRE WAS SUCCESSFULLY SNARED. ANGIOPLASTY WAS THEN PERFORMED WHICH RESTORED FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES, INC. PV31300 091210

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention