BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 1629977 · Received March 11, 2010

    Report

    Report Number
    3003603429-2010-00002
    Event Type
    Injury
    Date Received
    March 11, 2010
    Date of Event
    February 11, 2010
    Report Date
    March 11, 2010
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES INC.
    Product Code
    MCW
    PMA / PMN Number
    K093456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Description of Event or Problem · 1

    THE JETSTREAM G3 WAS ADVANCED TO TREAT A 4CM LESION IN THE PERONEAL TRUNK. TWO SLOW PASSES WERE MADE IN THE MINIMUM MODE AND SIGNIFICANT RESISTANCE WAS EXPERIENCED. THE DEVICE WAS TAKEN OUT AND CONTRAST WAS INJECTED AND A SIGNIFICANT DISSECTION WAS OBSERVED. THE DISSECTION WAS TREATED WITH PTA AND TWO STENTS WITH A SUCCESSFUL OUTCOME. THE PATIENT 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention