BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 1936096 · Received December 13, 2010

    Report

    Report Number
    3003603429-2010-00053
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 12, 2010
    Report Date
    December 10, 2010
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES, INC.
    Product Code
    MCW
    PMA / PMN Number
    K101221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 EVAL. 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.

    Description of Event or Problem · 1

    THE JETSTREAM G3 WAS ADVANCED TO TREAT A 2 CM CLOT LOCATED IN THE DISTAL POPLITEAL. AFTER 1 MIN 40 SECONDS OF RUN TIME, A PERFORATION OCCURRED DURING THE PROCEDURE. A PSEUDOANEURYSM DEVELOPED AND SURGERY WAS REQUIRED. PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES, INC. PV31300 100928

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention