BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 1917386 · Received December 2, 2010

    Report

    Report Number
    3003603429-2010-00050
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    November 4, 2010
    Report Date
    December 2, 2010
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES INC.
    Product Code
    MCW
    PMA / PMN Number
    K101221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. PERFORATION IS AN INHERENT RISK FOR THE TREATMENT OF PERIPHERAL VASCULAR DISEASE WITH PATHWAY MEDICAL'S JETSTREAM G3 SYS AND IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE IFU.

    Description of Event or Problem · 1

    THE JETSTREAM G3 WAS ADVANCED TO TREAT A MODERATELY CALCIFIED 6 CM LESION LOCATED IN THE PROXIMAL TO MID POPLITEAL ARTERY. AFTER 2 MINS AND 38 SECONDS OF TREATMENT, A SLIGHT PERFORATION WAS NOTICED. THE PERFORATION WAS TREATED WITH 4 BALLOON INFLATIONS AND THE PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES INC. PV31300 100901

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention