BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

    MDR report key: 7325520 · Received March 8, 2018

    Report

    Report Number
    3005168196-2018-00499
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Date of Event
    February 2, 2018
    Report Date
    February 7, 2018
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548012490
    PMA / PMN Number
    K160533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    510(K) #: K160449. RESULTS: THE 3MAX WAS FRACTURED APPROXIMATELY 42.0 CM FROM THE HUB. CONCLUSIONS: EVALUATION OF THE RETURNED 3MAX REVEALED IT WAS FRACTURED. THIS DAMAGE MAY HAVE BEEN A RESULT OF FORCEFULLY ADVANCING THE DEVICE AGAINST RESISTANCE WHILE MANIPULATING AT EXTREME ANGLES OUTSIDE THE PATIENT BODY. PENUMBRA CATHETERS ARE VISUALLY INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. 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 IN THE M1 OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE THE 3MAXC THROUGH A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), HOWEVER THE PROXIMAL END OF THE 3MAXC STILL OUTSIDE OF THE PATIENT BROKE IN HALF, DESPITE HAVING USED A GUIDEWIRE TO ADVANCE THE 3MAXC. THE 3MAXC WAS THEREFORE RETRACTED AND REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW 3MAXC, THE SAME ACE68 AND GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167524 PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F79987 00814548012490

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR