BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 1580043 · Received January 13, 2010

    Report

    Report Number
    3003603429-2009-00063
    Event Type
    Injury
    Date Received
    January 13, 2010
    Date of Event
    December 15, 2009
    Report Date
    January 13, 2010
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES, INC.
    Product Code
    MCW
    PMA / PMN Number
    K093456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 TECHNOLOGY FOR EVAL.

    Description of Event or Problem · 1

    THE JETSTREAM G3 WAS ADVANCED TO TREAT A SEVERELY CALCIFIED LESION IN THE TIBIAL PERONEAL TRUNK. AFTER COMPLETION TREATMENT, USING MINIMUM DIAMETER, A SMALL NON-FLOW LIMITING DISSECTION WAS NOTED. THE DISSECTION WAS TREATED WITH A BALLOON. THE PT WAS FINE AND WAS DISCHARGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention