BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURON MAX 6F 088 LONG SHEATH

    MDR report key: 7813727 · Received August 24, 2018

    Report

    Report Number
    3005168196-2018-01673
    Event Type
    Injury
    Date Received
    August 24, 2018
    Date of Event
    July 21, 2018
    Report Date
    July 25, 2018
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00814548012209
    PMA / PMN Number
    K111380
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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

    RESULTS: THE DISTAL TIP OF THE NEURON MAX WAS PEELED BACK, AND THE MARKER BAND WAS MISSING. THE C-CUT FROM WHERE THE MARKER BAND WAS LAMINATED INTO THE DISTAL TIP OF THE CATHETER WAS VISIBLE. THERE WAS A SMALL OVALIZATION APPROXIMATELY 77.0 FROM THE HUB, 5.0 CM FROM THE DISTAL TIP. CONCLUSIONS: EVALUATION OF THE RETURNED NEURON MAX REVEALED THE DISTAL TIP WAS FOLDED BACK AND THE MARKER BAND WAS MISSING. THE DISTAL TIP BECOMING FOLDED IS LIKELY DUE TO THE INTERACTION OF THE NEURON MAX WITH A PARENT DEVICE. THE NON-PENUMBRA SHORT SHEATH IDENTIFIED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THIS DAMAGE COULD NOT BE DETERMINED. THE DISTAL TIP FOLDING LIKELY CONTRIBUTED TO THE DETACHMENT OF THE MARKER BAND. OUR ANALYSIS REVEALED THE C-CUT IN THE NEURON MAX POLYMER INDICATING THE MARKER BAND WAS FULLY LAMINATED INTO THE CATHETER. IF THE MARKER BAND IS EXPOSED AND FORCEFULLY RETRACTED AGAINST RESISTANCE THE MARKER BAND MAY BECOME DISLODGED. THE ROOT CAUSE OF THE RESISTANCE COULD NOT BE DETERMINED. PENUMBRA CATHETERS ARE 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 MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NEURON MAX TO THE TARGET LOCATION USING A NON-PENUMBRA SHEATH. AFTER SUCCESSFULLY ASPIRATED THE THROMBUS USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) WITHIN THE NEURON MAX, THE PHYSICIAN FELT RESISTANCE WHILE RETRACTING THE NEURON MAX TO REMOVE IT. CONSEQUENTLY, THE RADIOPAQUE MARKER BAND AT THE DISTAL END OF THE NEURON MAX DISLODGED WHILE THE DEVICES WERE BEING REMOVED. THE MARKER BAND MIGRATED AND REMAINED STUCK IN THE DISTAL PORTION OF THE EXTERNAL CAROTID ARTERY (ECA) AND THE PHYSICIAN WAS UNABLE TO REMOVE IT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656348 NEURON MAX 6F 088 LONG SHEATH DQY DQY PENUMBRA, INC. F78933 00814548012209

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening| O