BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 2031346 · Received March 23, 2011

    Report

    Report Number
    3003603429-2011-00014
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 25, 2011
    Report Date
    March 23, 2011
    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 EVALUATION. DISTAL EMBOLIZATION 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 35 CM LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) TO THE ADDUCTOR CANAL. A PASS WAS MADE THROUGH TO THE DISTAL PORTION OF THE SFA, WHEN THE DEVICE STOPPED ASPIRATING. THE DEVICE WAS PULLED OUT AND AN ANGIOGRAM WAS TAKEN. THE SFA WAS OPENED WITH A SMALL LUMEN AND VERY SLOW FLOW. AN ANGIOGRAM WAS THEN TAKEN BELOW THE KNEE WHERE THROMBO-EMBOLI WAS AT THE TIBIAL PERONEAL (TP) TRUNK WITH NO FLOW IN THE PERSONAL AND POSTERIOR TIBIAL (PT). A RETRIEVAL CATHETER WAS USED ALONG WITH A THROMBOLYTIC AGENT, NITROGLYCERIN AND FINALLY BALLOON ANGIOPLASTY, WHICH EVENTUALLY OPENED UP THE PERONEAL ARTERY. THE PT WOULD NOT OPEN. THE PT LEFT WITH A ONE VESSEL RUN-OFF HOWEVER HER FOOT WAS STILL WARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES, INC. PV31300 110202

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention