BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 1844710 · Received September 23, 2010

    Report

    Report Number
    3003603429-2010-00042
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 23, 2010
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES INC.
    Product Code
    MCW
    PMA / PMN Number
    K101221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED AND THE CAUSE OF THE JETSTREAM G3 BECOMING STUCK ONTO THE GUIDEWIRE WAS THE BUSHING TIGHTENING ONTO THE GUIDEWIRE. THERE WAS NO INDICATION, HOWEVER, THAT THE DEVICE BECOMING STUCK ONTO THE GUIDEWIRE CAUSED THE DISTAL EMBOLIZATION. 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. ADDITIONALLY, IN-STENT RESTENOSIS PATIENTS ARE LISTED AS A SPECIAL PATIENT POPULATION (I.E., THE SAFETY AND EFFECTIVENESS OF THE JETSTREAM G3 SYSTEM HAS NOT BEEN ESTABLISHED IN THIS GROUP OF PATIENTS) IN THE IFU.

    Description of Event or Problem · 1

    THE JETSTREAM G3 WAS ADVANCED TO TREAT A SEVERELY CALCIFIED 30 CM IN STENT RESTENOSIS (ISR) LESION LOCATED IN THE MID TO DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). ONE PASS WAS MADE USING THE MINIMUM DIAMETER MODE THROUGH THE ENTIRE LENGTH OF THE TREATMENT AREA. WHILE RETRACTING THE DEVICE BACK, THE DEVICE BECAME STUCK ON THE GUIDEWIRE AND THE DEVICE COULD NOT MOVE OVER THE GUIDEWIRE. THE DEVICE AND GUIDEWIRE WERE REMOVED TOGETHER AS A UNIT FROM THE PATIENT. THERE WAS SIGNIFICANT EMBOLIZATION WHICH WAS TREATED WITH MANUAL ASPIRATION THROUGH A THROMBECTOMY CATHETER. ANGIOPLASTY WAS THEN USED TO FINISH THE CASE AND THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES INC. PV31300 100615

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention