BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM JETD REPERFUSION CATHETER

    MDR report key: 12800626 · Received November 11, 2021

    Report

    Report Number
    3005168196-2021-02550
    Event Type
    Malfunction
    Date Received
    November 11, 2021
    Date of Event
    October 15, 2021
    Report Date
    November 11, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548019802
    PMA / PMN Number
    K090752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M3 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE WHILE ADVANCING THE JETD WITH THE 3MAXC, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS NOT ABLE TO TRACK THE JETD THROUGH THE INTERNAL CAROTID ARTERY (ICA) LOOP. IT WAS REPORTED THAT THE 3MAXC WAS ABLE TO TRACK; HOWEVER, THE JETD WOULD NOT PASS THE OPHTHALMIC ARTERY. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1698696 PENUMBRA SYSTEM JETD REPERFUSION CATHETER NRY NRY PENUMBRA, INC. 5MAXJETDKIT F100126 00814548019802

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female