BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 2467135 · Received February 16, 2012

    Report

    Report Number
    3003603429-2012-00001
    Event Type
    Injury
    Date Received
    February 16, 2012
    Date of Event
    January 18, 2012
    Report Date
    January 18, 2012
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES INC.
    Product Code
    MCW
    PMA / PMN Number
    K110626
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED AND THE LOSS OF ASPIRATION AND GUIDEWIRE POSITION ISSUE ARE ATTRIBUTED TO A KINK/SHUNT OBSERVED IN THE CATHETER AT 37 INCHES FROM THE DISTAL END. THE ROOT CAUSE FOR THE DISTAL EMBOLI COULD NOT BE DETERMINED. THERE IS NO EVIDENCE THE OBSERVED DAMAGE CAUSED THE EMBOLIZATION. 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 NAVITUS DEVICE WAS USED TO TREAT LESIONS IN THE SFA AND PERONEAL. IT WAS REPORTED THAT THE DEVICE WOULD INTERMITTENTLY STOP ASPIRATING AND THE GUIDEWIRE LOOP WAS NOT GETTING LARGER AS THE DEVICE ADVANCED. UPON EVAL OF THE ARTERIES IN THE FOOT, DISTAL EMBOLI WAS OBSERVED. THE PHYSICIAN BALLOONED THE AFFECTED PEDAL ARTERIES WITHOUT SUCCESS. HE THEN INJECTED 4MG OF TPA INTO EACH AFFECTED PEDAL ARTERY SUCCESSFULLY RESTORING TRIPHASIC PULSES. THE PT IS DOING WELL FOLLOWING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES INC. 030542-004 110915

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention