BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 2212707 · Received August 11, 2011

    Report

    Report Number
    3003603429-2011-00031
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 12, 2011
    Report Date
    August 11, 2011
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES, INC.
    Product Code
    MCW
    PMA / PMN Number
    K110626
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. PERFORATION 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. IT IS IMPORTANT TO NOTE THE CATHETER WAS USED IN THE COMMON ILIAC ARTERY WHICH IS NOT AN APPROVED VASCULATURE PER THE IFU.

    Description of Event or Problem · 1

    THE JETSTREAM G3 WAS USED OFF LABEL IN THE COMMON ILIAC ARTERY. UPON THE THIRD PASS IN BLADES UP MODE, THE PATIENT EXPERIENCED BACK PAIN. THE DEVICE WAS REMOVED IMMEDIATELY AND AN ANGIOGRAM WAS PERFORMED. THE ANGIOGRAM REVEALED AN ILIAC PERFORATION. DR (B)(6) TREATED IT WITH A BALLOON AND PLACED THREE STENTS TO SEAL THE PERFORATION. THE PATIENT STABILIZED AND WAS RELEASED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES, INC. PV31300 110608

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention