BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM JETD REPERFUSION CATHETER

    MDR report key: 8670801 · Received June 5, 2019

    Report

    Report Number
    3005168196-2019-01084
    Event Type
    Malfunction
    Date Received
    June 5, 2019
    Date of Event
    May 2, 2019
    Report Date
    May 6, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    UDI-DI
    00814548019741
    PMA / PMN Number
    K142870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE, OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. ADDITIONAL 510(K) # S THAT ALSO APPLY TO THIS COMPLAINT: K160533, K161523.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POSTERIOR CEREBRAL ARTERY (PCA) USING A PENUMBRA SYSTEM JETD KIT. DURING THE PROCEDURE, WHILE ADVANCING THE PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD), THE PHYSICIAN EXPERIENCED RESISTANCE AT THE DISTAL P1 SEGMENT. CONSEQUENTLY, THE MID SHAFT OF THE JETD KINKED IN TRANSITION IN THE VERTEBRAL V3 SEGMENT. THEREFORE, THE JETD WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465747 PENUMBRA SYSTEM JETD REPERFUSION CATHETER DXE DXE PENUMBRA, INC. F87680 00814548019741

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR