BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM

    MDR report key: 1635962 · Received March 5, 2010

    Report

    Report Number
    1635962
    Event Type
    Injury
    Date Received
    March 5, 2010
    Date of Event
    February 23, 2010
    Report Date
    March 5, 2010
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES, INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A ATHRECTOMY/THROMBECTOMY WITH THE PATHWAY JETSTREAM DEVICE, THE GRAND SLAM GUIDEWIRE BROKE AT THE TIP OF THE JETSTREAM, RELEASING 10 CM OF THE GRAND SLAM WIRE INTO THE DISTAL EXTREMITY OF THE PATIENT. THIS WIRE WAS ULTIMATELY LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM CATHETER, PERIPHERAL, ATHERECTOMY MCW PATHWAY MEDICAL TECHNOLOGIES, INC. * 100119
    2 ASAHI GRAND SLAM WIRE, GUIDE, CATHETER DQX ABBOTT VASCULAR * *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| O| R