BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3 SF

    MDR report key: 2133573 · Received June 16, 2011

    Report

    Report Number
    3003603429-2011-00027
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 12, 2011
    Report Date
    June 16, 2011
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES, INC.
    Product Code
    MCW
    PMA / PMN Number
    K101221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATHWAY JETSTREAM G3 SF CATHETER WAS DISCARDED AFTER THE PROCEDURE AND THEREFORE NOT RETURNED TO PATHWAY MEDICAL TECHNOLOGIES FOR EVAL. AS NOTED IN THE IFU, A POSSIBLE OUTCOME OF ALLOWING THE DEVICE TO COME IN CONTACT WITH TIP OF THE GUIDEWIRE IS DETACHMENT, "DURING TREATMENT, DO NOT ALLOW THE CATHETER TIP TO COME IN CONTACT WITH, OR RUN OVER, THE SPRING TIP PORTION OF THE GUIDEWIRE. CONTACT MAY CAUSE DETACHMENT OF THE GUIDEWIRE TIP." IT IS IMPORTANT TO NOTE, THAT THE GUIDEWIRE USED IN THIS CASE IS A THUNDER GUIDEWIRE WHICH IS NOT A COMPATIBLE ACCESSORY AND THE IFU INCLUDES A CAUTION REGARDING THE USE OF GUIDEWIRES NOT LISTED FOR USE, "USE ONLY LISTED COMPATIBLE GUIDEWIRES AND INTRODUCERS WITH THE JETSTREAM G3 SYSTEM. USE OF ANY SUPPLIES NOT LISTED AS COMPATIBLE MAY COMPROMISE PERFORMANCE OF OR DAMAGE THE JETSTREAM G3 SYSTEM."

    Description of Event or Problem · 1

    THE JETSTREAM G3 SF WAS ADVANCED TO TREAT AN 8 CM LESION LOCATED IN THE DISTAL ANTERIOR TIBIAL (AT). THE DEVICE WAS USED IN THE AT DOWN TO THE FOOT. IT BECAME STUCK ON THE GUIDEWIRE WHILE IN RETRACTION MODE. THE DISTAL 2 CM OF THE GUIDEWIRE BECAME DETACHED AND STAYED IN THE FOOT DUE TO THE PHYSICIAN BEING UNABLE TO SNARE THE DETACHED GUIDEWIRE. THE PHYSICIAN WAS NOT CONCERNED AS FLOW TO THAT PART OF THE FOOT WAS COMPRISED PROXIMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 SF PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES, INC. PV31300 110331

    Patients

    Seq Age Sex Outcome Treatment
    1