BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

    MDR report key: 5259775 · Received December 1, 2015

    Report

    Report Number
    3005168196-2015-01215
    Event Type
    Malfunction
    Date Received
    December 1, 2015
    Date of Event
    October 26, 2015
    Report Date
    November 2, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548013961
    PMA / PMN Number
    K142458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION TO SECTION: K142458.

    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. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2015-01214. THE HOSPITAL DISPOSED OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE 64) AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX). DURING THE PROCEDURE, THE PHYSICIAN USED THE 3MAX TO NAVIGATE THE ACE64 TO THE M1 SECTION OF THE MCA, THEN REMOVED THE 3MAX AND STARTED ASPIRATING THE CLOT THROUGH THE ACE64; HOWEVER, RECANALIZATION WAS MILD AND THE THROMBUS APPEARED TO INVOLVE THE DISTAL M2 BRANCH AS WELL. THE PHYSICIAN DECIDED TO USE THE 3MAX AGAIN IN ORDER TO NAVIGATE THE ACE64 TO THE M2 BRANCH, BUT THE M2 WAS TOO TIGHT FOR THE ACE64 TO PASS THROUGH IT SO THE PHYSICIAN USED THE 3MAX FOR ASPIRATION; HOWEVER, NO CLOT OR BLOOD FLOW WAS VISIBLE IN THE ASPIRATION TUBING SO THEY DECIDED TO REMOVE THE 3MAX. THE PHYSICIAN PULLED THE 3MAX BACK GENTLY AND THEN WITH FORCE, BUT THE 3MAX DID NOT MOVE UNTIL IT BECAME ELONGATED AND THEY WERE ABLE TO RETRACT IT. THE 3MAX WAS REMOVED FROM THE PATIENT AND THE PROCEDURE CONTINUED USING ANOTHER MANUFACTURER'S DEVICE; HOWEVER, IT WAS ALSO UNSUCCESSFUL IN ESTABLISHING RECANALIZATION. THE PROCEDURE STOPPED SINCE RECANALIZATION COULD NOT BE ACHIEVED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787526 PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F64227 00814548013961

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR