BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

    MDR report key: 5102110 · Received September 24, 2015

    Report

    Report Number
    3005168196-2015-00942
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    June 11, 2014
    Report Date
    August 25, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548012803
    PMA / PMN Number
    K142458
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE, OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. A POTENTIAL ADVERSE EVENT WITH THE PENUMBRA SYSTEM INCLUDE INTRACRANIAL HEMORRHAGE AND IS INCLUDED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED COMPLICATION. INTRACRANIAL HEMORRHAGE IS A KNOWN AND ANTICIPATED COMPLICATION WITH THESE TYPES OF PROCEDURES AND IS NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. 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 NUMBERS: 3005168196-2015-000943, 3005168196-2015-000944. DEVICE WAS DISPOSED OF.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER (5MAX ACE), A NEURON MAX 088 DELIVERY CATHETER (NEURON MAX) AND A VELOCITY CATHETER. DURING THE PROCEDURE THE PATIENT EXPERIENCED A SUBARACHNOID HEMORRHAGE. NO ACTION WAS TAKEN TO TREAT THE EVENT AND THE EVENT WAS RESOLVED ON (B)(6) 2014. THE INVESTIGATOR REPORTED SUBARACHNOID HEMORRHAGE AS A NON-SERIOUS ADVERSE EVENT WITH AN UNRELATED RELATIONSHIP TO THE PENUMBRA SYSTEM, PROBABLE RELATIONSHIP TO THE ANGIOGRAPHIC PROCEDURE, AND POSSIBLE RELATIONSHIP TO IVTPA AND INDEX STROKE. THE COMMITTEE ADJUDICATED THE EVENT TO BE A SERIOUS ADVERSE EVENT WITH AN UNCERTAIN RELATIONSHIP TO THE PENUMBRA SYSTEM, NEURON MAX, VELOCITY CATHETER AND DEFINITE RELATIONSHIP TO THE ANGIOGRAPHIC PROCEDURE, POSSIBLE RELATIONSHIP TO IVTPA, AND PROBABLE RELATIONSHIP TO INDEX STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630736 PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F41552 00814548012803

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other