BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 2031361 · Received March 23, 2011

    Report

    Report Number
    3003603429-2011-00015
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 22, 2011
    Report Date
    March 23, 2011
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES, INC.
    Product Code
    MCW
    PMA / PMN Number
    K101221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO INDICATION, BASED ON THE PHYSICAL EVAL OF THE RETURNED DEVICE AND THE REPORTED EVENT, THAT THE DEVICE FAILED TO PERFORM AS INTENDED (CAUSING A MALFUNCTION) LEADING TO THE PERFORATION. PERFORATION 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. IT IS IMPORTANT TO NOTE THAT A VIPER GUIDEWIRE WAS USED IN THIS CASE BUT IS NOT A COMPATIBLE ACCESSORY. THE IFU INCLUDES A CAUTION REGARDING THE USE OF GUIDEWIRES NOT LISTED FOR USE, "USE ONLY LISTED COMPATIBLE GUIDEWIRES AND THE 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 WAS ADVANCED TO TREAT A 2 CM LESION LOCATED IN THE MID POPLITEAL. THE DEVICE WAS RETRACTED TWICE OUT OF THE PT TO SHOOT CONTRAST AND DURING THE THIRD PASS, RPM ISSUES WERE ENCOUNTERED WHILE TRYING TO ENGAGE THE LESION. THE DEVICE WAS REMOVED FROM THE PT AND THERE WAS TISSUE WRAP NOTED ON THE GUIDEWIRE AND DEVICE. A PERFORATION WAS NOTED. THE PHYSICIAN BALLOONED THE AREA WHICH CONTAINED THE BLEEDING AND THE PT HAD GOOD OUTFLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES, INC. PV31300 101222

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention