BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 1761723 · Received July 16, 2010

    Report

    Report Number
    3003603429-2010-00027
    Event Type
    Injury
    Date Received
    July 16, 2010
    Date of Event
    June 16, 2010
    Report Date
    July 16, 2010
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES INC.
    Product Code
    MCW
    PMA / PMN Number
    K101221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. DISTAL EMBOLI 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 MODERATELY CALCIFIED 1 CM LESION LOCATED IN THE POPLITEAL. AFTER 4 MINUTES 6 SECONDS OF TREATMENT USING THE JETSTREAM G3, THE PROCEDURE WAS COMPLETED WITH A GOOD RESULT. AN ANGIOGRAM WAS TAKEN AT THE TRIFURCATION SHOWING GOOD FLOW. AFTER THE PROCEDURE, THE ENTIRE FOOT TURNED BLUE, THOUGHT TO BE DUE TO DISTAL EMBOLI. AN EXTERNAL NITRO PATCH WAS PUT ON THE PT'S FOOT. FOLLOW-UP WITH THE LAB WAS MADE AND THE SITUATION HAD RESOLVED ITSELF.

    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