BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 2428604 · Received January 20, 2012

    Report

    Report Number
    3003603429-2011-00038
    Event Type
    Injury
    Date Received
    January 20, 2012
    Date of Event
    December 22, 2011
    Report Date
    December 29, 2011
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES INC.
    Product Code
    MCW
    PMA / PMN Number
    K110626
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATHWAY MEDICAL JETSTREAM DEVICE HAS NOT YET BEEN EVALUATED. THE PHYSICIAN IS IN THE PROCESS OF RETURNING THE DEVICE FOR EVAL AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    DURING THE USE OF THE JETSTREAM NAVITUS SYSTEM ON (B)(6) 2011 THE DISTAL END OF THE GUIDEWIRE WITH SPIDER FILTER WAS SEVERED. THE DEVICE WAS REMOVED AND MULTIPLE ATTEMPTS TO RETRIEVE THE TIP WERE MADE. RETRIEVAL WAS ACCOMPLISHED WITH RADIAL JAW FORCEPS. THE PT WAS THEN TREATED WITH 2 COVERED STENTS AND PTA. FOLLOW UP IVUS WAS NOT DONE PER PROTOCOL DUE TO URGENT NEED TO REPAIR SFA DISSECTION SECONDARY TO JETSTREAM DEVICE. THE PT IS DOING FINE AFTER 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 110804

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention