BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM G3

    MDR report key: 1844711 · Received September 23, 2010

    Report

    Report Number
    3003603429-2010-00041
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 23, 2010
    Manufacturer
    PATHWAY MEDICAL TECHNOLOGIES INC.
    Product Code
    MCW
    PMA / PMN Number
    K101221
    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 EVALUATION. 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.

    Description of Event or Problem · 1

    THE JETSTREAM G3 WAS ADVANCED TO TREAT A SMALL LESION LOCATED IN THE PROXIMAL ANTERIOR TIBIAL ARTERY. THE DEVICE WAS ADVANCED AND ENGAGED IN THE MINIMUM DIAMETER MODE JUST PROXIMAL TO THE BEND IN THE ANTERIOR TIBIAL ARTERY. THE PATIENT EXPERIENCED SOME CALF PAIN. THE DEVICE WAS REMOVED AND AN ANGIOGRAM REVEALED A PERFORATION AT THE TREATMENT SITE. ANGIOPLASTY WAS PERFORMED AND CONTAINMENT OF THE EXTRAVASATION WAS ACHIEVED. THE DECISION WAS MADE TO END THE PROCEDURE AND PERFORM AN ULTRASOUND IN THE MORNING. PALPABLE PULSE WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JETSTREAM G3 PERIPHERAL VASCULAR ATHERECTOMY SYSTEM MCW PATHWAY MEDICAL TECHNOLOGIES INC. PV31300 100624

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention