BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM RED72 REPERFUSION CATHETER

    MDR report key: 14527249 · Received May 27, 2022

    Report

    Report Number
    3005168196-2022-00242
    Event Type
    Injury
    Date Received
    May 27, 2022
    Date of Event
    May 4, 2022
    Report Date
    November 10, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00815948023932
    PMA / PMN Number
    K211654
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 1.3005168196-2022-00241.

    Additional Manufacturer Narrative · 0

    VESSEL PERFORATION IS INCLUDED AS A POSSIBLE COMPLICATION IN THE INSTRUCTIONS FOR USE FOR THE PENUMBRA SYSTEM. PLEASE NOTE THAT THE DEVICE ASSOCIATED WITH THIS COMPLAINT WAS EXPECTED TO BE RETURNED; HOWEVER, ADDITIONAL INFORMATION RECEIVED FROM THE PENUMBRA SALES REPRESENTATIVE INDICATED THAT THE DEVICE IS NO LONGER AVAILABLE FOR RETURN. THEREFORE, 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: 1.3005168196-2022-00241.

    Description of Event or Problem · 0

    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 RED 72 REPERFUSION CATHETER (RED72), A VELOCITY DELIVERY MICROCATHETER (VELOCITY), A NON-PENUMBRA STENT RETRIEVER, A PENUMBRA SELECT CATHETER, A NON-PENUMBRA SHEATH, AND TWO GUIDEWIRES. IT WAS REPORTED THAT THERE WAS A SMALL DISSECTION IN THE INTERNAL CAROTID ARTERY (ICA) PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN OBTAINED ACCESS IN THE FEMORAL ARTERY USING THE 8F SHEATH. THEN, THE PHYSICIAN ADVANCED THE NEURON MAX INTO THE LEFT INTERNAL CAROTID ARTERY (ICA) USING THE SELECT CATHETER AND GUIDEWIRE. NEXT, THE PHYSICIAN ADVANCED THE RED72 OVER THE VELOCITY, AND GUIDEWIRE THROUGH THE NEURON MAX TO THE CLOT IN THE TARGET VESSEL. NEXT, THE PHYSICIAN REMOVED THE GUIDEWIRE AND ADVANCED THE STENT RETRIEVER DEVICE THROUGH THE VELOCITY AND INTO THE TARGET VESSEL. AFTER REMOVING THE VELOCITY, THE PHYSICIAN INITIATED ASPIRATION AND SUCCESSFULLY COMPLETED ONE PASS USING THE RED72 AND STENT RETRIEVER DEVICE. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE RED72 AND STENT RETRIEVER DEVICE. THE PHYSICIAN THEN COMPLETED ANOTHER PASS USING THE SAME STEPS. AFTER THE SECOND PASS, WHILE RETRACTING THE RED72 AND STENT RETRIEVER DEVICE THROUGH THE NEURON MAX, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE NEURON MAX AS WELL. UPON REMOVAL OF THE DEVICES, THE PHYSICIAN NOTICED THE RED72 TO BE UNRAVELED IN TWO AREAS AT THE DISTAL END AND THE NEURON MAX TO BE OVALIZED AT THE DISTAL END. THEREFORE, THE NEURON MAX WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PHYSICIAN THEN INSERTED A NEW NEURON MAX TO TAKE THE FINAL PICTURES. THE SIZE OF THE DISSECTION IN THE ICA WAS NOTED TO BE LARGER THAN THE SIZE AT THE BEGINNING OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER THE FINAL PICTURES WERE TAKEN. THE USE OF THE RED72 AND NEURON MAX MAY HAVE CONTRIBUTED TO THE WORSENING OF THE PRE-EXISTING DISSECTION IN THE ICA. IT SHOULD BE NOTED THAT NO ACTION WAS TAKEN TO TREAT THE DISSECTION OF THE ICA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2202349 PENUMBRA SYSTEM RED72 REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F109223 00815948023932

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Other