BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURON MAX 6F 088 LONG SHEATH

    MDR report key: 11745892 · Received April 29, 2021

    Report

    Report Number
    3005168196-2021-00903
    Event Type
    Injury
    Date Received
    April 29, 2021
    Date of Event
    March 23, 2021
    Report Date
    July 21, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    UDI-DI
    00814548012162
    PMA / PMN Number
    K111380
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    POTENTIAL ADVERSE EVENTS IN THE LABELING WITH THE NEURON MAX SYSTEM INCLUDE, BUT ARE NOT LIMITED TO, DISTAL EMBOLIZATION, DISSECTION, EMBOLI, INCLUDING DEATH. EVALUATION OF THE RETURNED NEURON MAX CONFIRMED A KINK IN ITS DISTAL SHAFT. IF THE DEVICE IS FORCEFULLY MANIPULATED AGAINST RESISTANCE, DAMAGE SUCH AS THIS MAY OCCUR. FURTHER EVALUATION OF THE DEVICE REVEALED THAT THE DISTAL SHAFT OF THE CATHETER LUMEN WAS DAMAGED, THE COILS WERE EXPOSED, AND THE DEVICE DISTAL TIP WAS OVALIZED. THE ROOT CAUSE OF THIS DAMAGE COULD NOT BE DETERMINED. THIS DAMAGE WAS NOT IDENTIFIED IN THE REPORTED COMPLAINT. THIS DAMAGE WAS LIKELY INCIDENTAL AND MAY HAVE OCCURRED POST-PROCEDURE PRIOR TO SHIPMENT BACK TO PENUMBRA. 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. H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    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), A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NEURON MAX TO THE ILIAC ARTERY. SUBSEQUENTLY, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO FURTHER ADVANCE THE NEURON MAX TO THE CERVICAL ARTERY. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE NEURON MAX. UPON REMOVAL, IT WAS NOTICED THAT THE DISTAL END OF THE NEURON MAX WAS KINKED. AFTERWARDS, THE PHYSICIAN INJECTED CONTRAST AND NOTICED THERE WAS DISTAL EMBOLIZATION AND DISSECTION IN THE ILIAC ARTERY. THE PROCEDURE WAS COMPLETED USING A NEW NEURON MAX, THE SAME ACE68, THE SAME 3MAXC. IT WAS ALSO REPORTED THAT THERE IS A POSSIBLE RELATIONSHIP BETWEEN THE NEURON MAX AND THE DISTAL EMBOLIZATION AND DISSECTION. LATER, TWO DAYS POST-PROCEDURE, THE PATIENT WAS SEEN AT THE HOSPITAL FOR OBSERVATION AND WAS DISCHARGED WITHOUT ANY TREATMENT FOR THE DISTAL EMBOLIZATION AND DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639811 NEURON MAX 6F 088 LONG SHEATH DQY DQY PENUMBRA, INC. PNML6F088904M H10129 00814548012162

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other