BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 1622780 · Received March 3, 2010

    Report

    Report Number
    3003603429-2010-00001
    Event Type
    Injury
    Date Received
    March 3, 2010
    Date of Event
    February 1, 2010
    Report Date
    March 3, 2010
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES INC.
    Product Code
    MCW
    PMA / PMN Number
    K093456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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.

    Description of Event or Problem · 1

    THE JETSTREAM G3 WAS ADVANCED TO TREAT A SEVERELY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). TWO PASSES USING BOTH MINIMUM AND MAXIMUM DIAMETER MODES WERE SUCCESSFULLY MADE WITH GOOD TECHNIQUE AND WITHOUT INCIDENT. A SUBSEQUENT ANGIOGRAM REVEALED NO FLOW IN THE DISTAL RUNOFF. THE G3 DEVICE WAS THEN BEING REMOVED USING RETRACTION MODE BUT STALLED WHEN THE TIP REACHED THE AORTIC BIFURCATION. THE DEVICE WAS THEN STUCK ON THE GUIDEWIRE AND WOULD NOT RETRACT AT ALL. THE G3 AND GUIDEWIRE HAD TO BE COMPLETELY REMOVED TOGETHER. THE PHYSICIAN THEN USED ANOTHER MANUFACTURER'S ASPIRATION CATHETER TO REMOVE EMBOLI IN THE POST-TIBIAL ARTERY AND DID RETRIEVE SEVERAL PIECES OF PARTICULATE MATTER. A LARGER PIECE WAS VISUALIZED ANGIOGRAPHICALLY IN THE DISTAL POST-TIBIAL AT THE LEVEL OF THE LATERAL MALLEOLUS THAT COULD NOT BE RETRIEVED BECAUSE THE ASPIRATION CATHETER WOULD NOT REACH. ACT WAS 270 INTRA-PROCEDURE. FINAL PT OUTCOME WAS OKAY AND BLOOD FLOW WAS RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES INC. PV31300 100104

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention