BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER

    MDR report key: 16496077 · Received March 7, 2023

    Report

    Report Number
    3005168196-2023-00097
    Event Type
    Injury
    Date Received
    March 7, 2023
    Date of Event
    January 1, 2017
    Report Date
    March 7, 2023
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K160449
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. 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 PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 0

    DURING ITS POST-MARKET SURVEILLANCE ACTIVITIES ON (B)(6) 2023, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, "A DIRECT ASPIRATION FIRST PASS TECHNIQUE FOR VERTEBRA-BASILAR OCCLUSION: A RETROSPECTIVE COMPARISON TO STENT RETRIEVER" (ONODERA ET AL. 2022). IN THIS SINGLE CENTER RETROSPECTIVE STUDY, TWENTY-THREE PATIENTS WERE TREATED FOR ACUTE ISCHEMIC STROKE (AIS) AND VERTEBRA-BASILAR ARTERY OCCLUSION USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60) OR A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68) BETWEEN (B)(6) 2017 AND (B)(6) 2020.NINE PATIENTS EXPERIENCED HEMORRHAGE POST-PROCEDURE. HOWEVER, THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS AND THE RELATIONSHIP BETWEEN THE HEMORRHAGES AND USE OF THE PENUMBRA REPERFUSION CATHETERS WAS NOT SPECIFIED.TWO PATIENTS EXPERIENCED A SYMPTOMATIC INTRACRANIAL HEMORRHAGE (SICH) POST-PROCEDURE. HOWEVER, THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS AND THE RELATIONSHIP BETWEEN THE SICHS AND USE OF THE PENUMBRA REPERFUSION CATHETERS WAS NOT SPECIFIED.IT WAS ALSO REPORTED THAT THE PHYSICIAN WAS UNABLE TO ACCESS THE TARGET LOCATION USING THE PENUMBRA REPERFUSION CATHETER DUE TO THE TORTUOSITY OF THE VERTEBRAL ARTERY. THEREFORE, THE PHYSICIAN USED A STENT RETRIEVER AND AN ANCHORING TECHNIQUE TO DELIVER THE PENUMBRA REPERFUSION CATHETER TO THE CLOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716471 PENUMBRA SYSTEM REPERFUSION CATHETER NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other