BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER

    MDR report key: 15398409 · Received September 12, 2022

    Report

    Report Number
    3005168196-2022-00416
    Event Type
    Injury
    Date Received
    September 12, 2022
    Date of Event
    January 1, 2011
    Report Date
    September 9, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K160449
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. DISTAL EMBOLIZATION, HEMATOMA, AND INTRACRANIAL HEMORRHAGE ARE INCLUDED AS POSSIBLE COMPLICATIONS 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. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 3005168196-2022-00417, 3005168196-2022-00418, 3005168196-2022-00419.

    Description of Event or Problem · 0

    DURING ITS POST-MARKET SURVEILLANCE ACTIVITIES ON 16-AUG-2022, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, "ENDOVASCULAR THROMBECTOMY FOR M2 OCCLUSIONS: COMPARISON BETWEEN FORCED ARTERIAL SUCTION THROMBECTOMY AND STENT RETRIEVER THROMBECTOMY" (KIM ET AL. 2016). IN THIS SINGLE CENTER RETROSPECTIVE REVIEW, TWENTY-FIVE PATIENTS UNDERWENT ENDOVASCULAR THROMBECTOMY PROCEDURES TO TREAT OCCLUSIONS IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM REPERFUSION CATHETER 041 OR A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC) BETWEEN JANUARY 2011 AND JUNE 2015. IT WAS REPORTED THAT THREE PATIENTS EXPERIENCED DISTAL EMBOLIZATION AFTER USE OF A PENUMBRA SYSTEM REPERFUSION CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED. THREE PATIENTS EXPERIENCED A HEMORRHAGIC INFARCTION TYPE ONE AFTER USE OF A PENUMBRA SYSTEM REPERFUSION CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED. ONE PATIENT EXPERIENCED A PARENCHYMAL HEMATOMA AFTER USE OF A PENUMBRA SYSTEM REPERFUSION CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED. ONE PATIENT EXPERIENCED A SYMPTOMATIC INTRACRANIAL HEMORRHAGE (SICH) AFTER USE OF A PENUMBRA SYSTEM REPERFUSION CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED. IT WAS ALSO REPORTED THAT REPERFUSION WAS NOT ACHIEVED IN FIVE PATIENTS AFTER COMPLETING THREE PASSES WITH THE PENUMBRA SYSTEM REPERFUSION CATHETER. THE PHYSICIAN PERFORMED A DEVICE SWITCH AND CONTINUED TREATMENT WITH A STENT RETRIEVER AND INTRA-ARTERIAL TIROFIBAN INFUSION. NO ADDITIONAL INFORMATION WAS PROVIDED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE, NOR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, THIS REPORT ADDRESSES ALL MALFUNCTIONS AND/OR ADVERSE EVENTS WITHIN THIS LITERATURE SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2215545 PENUMBRA SYSTEM REPERFUSION CATHETER NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other