BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 1689900 · Received March 25, 2010

    Report

    Report Number
    3003603429-2010-00008
    Event Type
    Injury
    Date Received
    March 25, 2010
    Date of Event
    February 23, 2010
    Report Date
    March 25, 2010
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES, INC.
    Product Code
    MCW
    PMA / PMN Number
    K092332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 EVAL. THE COMPLAINT NOTES THAT THE GUIDEWIRE WAS COMING OUT OF THE BACK OF THE CONTROL POD TWISTING ON ITSELF AND IT APPEARED TO TWIST IN THE VESSEL. THE IFU INCLUDES A CAUTION ON GUIDEWIRE MGMT TECHNIQUE, "HOLD THE GUIDEWIRE FIRMLY DURING CATHETER RETRACTION PROCESS. FAILURE TO DO SO MAY RESULT IN GUIDEWIRE ROTATION WITHIN THE VESSEL." INITIAL REPORTER (USER) SUBMITTED REPORT TO FDA (B) (4)

    Description of Event or Problem · 1

    THE JETSTREAM G3 WAS ADVANCED TO TREAT AN APPROXIMATELY 35CM LESION IN A SURGICALLY PLACED SYNTHETIC GRAFT LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE WAS USED IN THE MINIMUM DIAMETER MODE AND AT THE DISTAL PART OF THE GRAFT THE DEVICE ENCOUNTERED RESISTANCE. THE PHYSICIAN PULLED THE DEVICE BACK AND MOVED BEYOND THAT AREA. IT WAS NOTICED THAT THE GUIDEWIRE COMING OUT OF THE BACK OF THE CONTROL POD, TWISTED ON ITSELF AND IT APPEARED TO TWIST IN THE VESSEL. THE GUIDEWIRE BECAME STUCK AND THE PHYSICIAN PULLED OUT THE G3 AND GUIDEWIRE AS ONE UNIT. IT WAS THEN NOTICED THAT 10 CM (PER USER REPORT) OF THE GUIDEWIRE WAS LEFT BEHIND IN THE PERONEAL (DISTAL EXTREMITY) OF THE PT. THE GUIDEWIRE WAS LEFT IN THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention