BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER

    MDR report key: 17012926 · Received May 26, 2023

    Report

    Report Number
    3005168196-2023-00249
    Event Type
    Injury
    Date Received
    May 26, 2023
    Date of Event
    April 27, 2023
    Report Date
    July 7, 2023
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00815948024359
    PMA / PMN Number
    K203440
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 WAS DISPOSED OF AND IS NO LONGER AVAILABLE FOR RETURN. FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE, OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. INTRACRANIAL HEMORRHAGE IS INCLUDED AS A POSSIBLE COMPLICATION IN THE INSTRUCTIONS FOR USE (IFU) FOR THE PENUMBRA SYSTEM. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62). ON (B)(6) 2023, 24 HR FOLLOW-UP COMPUTED TOMOGRAPHY (CT) DEMONSTRATED A SMALL-VOLUME SUBARACHNOID HEMORRHAGE PRESENT IN THE LEFT SYLVIAN FISSURE. THE SUBARACHNOID HEMORRHAGE WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE PENUMBRA SYSTEM AND A PROBABLE RELATIONSHIP TO THE INDEX PROCEDURE. THE EVENT IS CONSIDERED ONGOING. ON (B)(6) 2023, AN UPDATE WAS RECEIVED INDICATING THAT THE EVENT WAS RESOLVED AS THE PATIENT STARTED COUMADIN.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE LEFT M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER (RED62). ON (B)(6) 2023, 24 HR FOLLOW-UP COMPUTED TOMOGRAPHY (CT) DEMONSTRATED A SMALL-VOLUME SUBARACHNOID HEMORRHAGE PRESENT IN THE LEFT SYLVIAN FISSURE. THE SUBARACHNOID HEMORRHAGE WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE PENUMBRA SYSTEM AND A PROBABLE RELATIONSHIP TO THE INDEX PROCEDURE. THE EVENT IS CONSIDERED ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1768617 PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F00000997 00815948024359

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other