BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 2023564 · Received March 16, 2011

    Report

    Report Number
    3003603429-2011-00011
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES, INC.
    Product Code
    MCW
    PMA / PMN Number
    K101221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATHWAY JETSTREAM G3 CATHETER WAS DISCARDED AFTER THE PROCEDURE AND THEREFORE WAS NOT RETURNED TO PATHWAY MEDICAL TECHNOLOGIES FOR EVALUATION. NOTE: GRAFT IS NOT INCLUDED IN THE INDICATIONS FOR THE PATHWAY JETSTREAM G3 CATHETER.

    Description of Event or Problem · 1

    THE JETSTREAM G3 WAS ADVANCED TO TREAT A COMPLETELY OCCLUDED 15 CM LESION LOCATED IN A SUPERFICIAL FEMORAL ARTERY (SFA) - POPLITEAL VEIN GRAFT. ONE PASS WAS MADE USING MINIMUM DIAMETER MODE AND A PASS WAS MADE USING MAXIMUM DIAMETER MODE. IT WAS NOTICED THAT ASPIRATION WAS NOT AS BRISK AS IT WAS INITIALLY, HOWEVER IT WAS STILL ASPIRATING. DOCTOR WAS THEN ADVISED TO STOP AFTER A PASS WAS MADE USING MAXIMUM DIAMETER MODE WHERE A FEW RPM DROPS OCCURRED. AN ANGIOGRAM THEN REVEALED A WIDELY PATENT GRAFT WITH A SLIGHT DISSECTION AT THE DISTAL POPLITEAL. THE PHYSICIAN USED A BALLOON WITH A GOOD END RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES, INC. PV31300 110112

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention