BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM JETD REPERFUSION CATHETER

    MDR report key: 8373849 · Received February 27, 2019

    Report

    Report Number
    3005168196-2019-00364
    Event Type
    Malfunction
    Date Received
    February 27, 2019
    Date of Event
    January 28, 2019
    Report Date
    January 28, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548019741
    PMA / PMN Number
    K090752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510(K)# THAT ALSO APPLIES TO THIS COMPLAINT: K133317. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A LESION IN THE P1 SEGMENT OF THE POSTERIOR CEREBRAL ARTERY (PCA) USING A PENUMBRA SYSTEM JETD KIT. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS VERY TORTUOUS AND WITH VERY THIN ARTERIES. DURING THE PROCEDURE, WHILE ADVANCING THE PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) THROUGH A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO TRACK THE JETD THROUGH THE NON-DOMINANT VERTEBRAL ARTERY DUE TO THE TORTUOSITY OF THE VESSEL. THEREFORE, THE JETD WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW JETD AND THE SAME NEURON MAX. IT IS UNKNOWN IF THERE WAS ANY ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168100 PENUMBRA SYSTEM JETD REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F86472 00814548019741

    Patients

    Seq Age Sex Outcome Treatment
    1