BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 1643226 · Received March 25, 2010

    Report

    Report Number
    3003603429-2010-00007
    Event Type
    Injury
    Date Received
    March 25, 2010
    Date of Event
    February 25, 2010
    Report Date
    March 25, 2010
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES, INC.
    Product Code
    MCW
    PMA / PMN Number
    K093456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. IT IS IMPORTANT TO NOTE THAT THE SPIDER GUIDEWIRE IS NOT A COMPATIBLE ACCESSORY AND THE IFU INCLUDES A CAUTION REGARDING THE USE OF THE GUIDEWIRE 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." IN-STENT RESTENOSIS PATIENTS ARE LISTED AS A SPECIAL PATIENT POPULATION (I.E., THE SAFETY AND EFFECTIVENESS OF THE JETSTREAM G3 SYSTEM HAS NOT BEEN ESTABLISHED IN THIS GROUP OF PATIENTS) IN THE IFU.

    Description of Event or Problem · 1

    THE JETSTREAM G3 WAS ADVANCED TO TREAT A 35CM IN-STENT RESTENOSIS (ISR) LESION LOCATED IN THE SFA. ANOTHER MANUFACTURER'S GUIDEWIRE WITH A FILTER WAS USED IN THIS CASE. TWO PASSES WERE MADE USING THE MINIMUM DIAMETER MODE AND ONE PASS WAS MADE USING THE MAXIMUM DIAMETER MODE. AFTER WITHDRAWING THE DEVICE AND PULLING BACK THE GUIDEWIRE, THE FILTER WAS DETACHED AND REMAINED IN THE LEG. THE PHYSICIAN TRIED TO SNARE IT OUT BUT WAS UNSUCCESSFUL AND DECIDED THAT THE BASKET WAS IN A SUBINTIMAL SPACE. A STENT WAS PUT OVER THE FILTER WITH A GOOD FINAL RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES, INC. PV31300 100126

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention