BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

    MDR report key: 5193136 · Received October 30, 2015

    Report

    Report Number
    3005168196-2015-01117
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Date of Event
    October 1, 2015
    Report Date
    October 1, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548012803
    PMA / PMN Number
    K133317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. HOSPITAL DISPOSED OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    CORRECTION TO PMA/510(K): K133317.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE). DURING THE PROCEDURE, AFTER ASPIRATION, THE PHYSICIAN REMOVED THE 5MAX ACE FROM THE PATIENT FOR LATER USE IN THE SAME PROCEDURE. HOWEVER, UPON REMOVAL, THE 5MAX ACE WAS FOUND TO BE STRETCHED. THE PROCEDURE WAS COMPLETED USING A NEW 5MAX ACE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722732 PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F64640 00814548012803

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR