BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3 L

    MDR report key: 1643688 · Received March 26, 2010

    Report

    Report Number
    3003603429-2010-00009
    Event Type
    Injury
    Date Received
    March 26, 2010
    Date of Event
    February 24, 2010
    Report Date
    March 26, 2010
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES INC.
    Product Code
    MCW
    PMA / PMN Number
    K093918
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATHWAY JETSTREAM G3 L CATHETER WAS DISCARDED AFTER THE PROCEDURE AND THEREFORE, NOT RETURNED TO PATHWAY MEDICAL TECHNOLOGIES FOR EVALUATION. IT IS NOTED IN THE IFU THAT THE REFERENCE VESSEL DIAMETER MUST BE CONFIRMED PRIOR TO USE, "CONFIRM THAT THE REFERENCE VESSEL DIAMETER PROXIMAL TO THE LESION IS GREATER THAN OR EQUAL TO 3.5MM BEFORE USING THE JETSTREAM G3 L CATHETER." THE REFERENCE VESSEL DIAMETER FOR THIS PATIENT WAS RECORDED AS 2.7MM.

    Description of Event or Problem · 1

    THE JETSTREAM G3 L WAS ADVANCED TO TREAT A MODERATELY CALCIFIED 9CM LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). AFTER TWO SUCCESSFUL PASSES IN THE MINIMUM DIAMETER MODE AND 1 SUCCESSFUL PASS IN THE MAXIMUM DIAMETER MODE, THE DEVICE MET SOME RESISTANCE. THE CATHETER WAS PULLED OUT AND AN ANGIOGRAM REVEALED A PERFORATION IN THE PROXIMAL SPA. THE PERFORATION WAS TREATED WITH A BALLOON AND VIABAHN STENT AND THE FINAL ANGIOGRAM LOOKED GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 L PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES INC. PV31400 100209

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention