BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G2

    MDR report key: 1349881 · Received March 19, 2009

    Report

    Report Number
    3003603429-2009-00018
    Event Type
    Injury
    Date Received
    March 19, 2009
    Date of Event
    March 2, 2009
    Report Date
    March 19, 2009
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES, INC.
    Product Code
    MCX
    PMA / PMN Number
    K083837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE JETSTREAM G2 CATHETER WAS DISCARDED AFTER THE PROCEDURE, AND THEREFORE, NOT RETURNED TO PATHWAY MEDICAL TECHNOLOGIES FOR EVALUATION. IN-STENT RESTENOSIS PTS ARE LISTED AS A SPECIAL PT POPULATION IN THE IFU AND ARE NOT INCLUDED IN THE INDICATIONS FOR USE.

    Description of Event or Problem · 1

    THE JETSTREAM G2 CATHETER WAS USED TO TREAT A LONG OCCLUDED IN-STENT RESTENOSIS LESION IN THE SFA. MULTIPLE PASSES WERE MADE IN THE MINIMUM DIAMETER MODE AND TWO PASSES WERE MADE IN THE MAXIMUM DIAMETER MODE. AN ANGIOGRAM TAKEN AFTER THE LAST JETSTREAM PASS, SHOWED A LARGE EMBOLISM IN THE POPLITEAL ARTERY. DURING THE ATTEMPTED RETRIEVAL, THE EMBOLISM MOVED DOWNSTREAM INTO THE PERONEAL AND POSTERIOR TIBIAL ARTERIES. PART OF THE EMBOLISM WAS UNRECOVERABLE AND WAS STENTED. NO FURTHER TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G2 PERPHERAL ATHERECTOMY CATHETER MCX PATHWAY MEDICAL TECHNOLOGIES, INC. PV20300 090129

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention