BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM

    MDR report key: 9050076 · Received September 13, 2019

    Report

    Report Number
    3005168196-2019-01748
    Event Type
    Injury
    Date Received
    September 13, 2019
    Date of Event
    December 13, 2018
    Report Date
    April 15, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K160449
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. POTENTIAL ADVERSE EVENTS IN THE LABELING WITH THE PENUMBRA SYSTEM INCLUDE, BUT ARE NOT LIMITED TO, HEMATOMA OR HEMORRHAGE AT THE SITE, INABILITY TO COMPLETELY REMOVE THROMBUS, INTRACRANIAL HEMORRHAGE, ISCHEMIA, INCLUDING DEATH. THEREFORE, IT WAS DETERMINED THAT THE REPORTED ADVERSE EVENTS WERE ANTICIPATED COMPLICATIONS. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2019-01749.

    Description of Event or Problem · 1

    PENUMBRA INC. BECAME AWARE ON 2019-04-15 DURING ITS POST-MARKET SURVEILLANCE ACTIVITIES, OF A NEURORADIOLOGY JOURNAL TITLED, "SINGLE-CENTER USING 3MAX OR 4MAX REPERFUSION CATHETER FOR THE TREATMENT OF ACUTE ISCHEMIC STROKE WITH DISTAL ARTERIAL OCCLUSIONS IN PATIENTS NOT ELIGIBLE FOR INTRAVENOUS FIBRINOLYSIS" (ROMANO ET AL. 2018). IT WAS REPORTED THAT 42 PATIENTS UNDERWENT A THROMBECTOMY PROCEDURE USING PENUMBRA SYSTEM REPERFUSION CATHETERS. IT WAS NOTED THAT HAEMORRHAGIC COMPLICATIONS WERE OBSERVED IN TWO PROCEDURES. THERE IS NO ALLEGATION WITHIN THE ARTICLE THAT A MALFUNCTION OF THE PENUMBRA SYSTEM OCCURRED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE OR PATIENT INFORMATION FROM THE ARTICLE, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, THIS REPORT ADDRESSES ALL ADVERSE EVENTS WITHIN THIS LITERATURE SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815871 PENUMBRA SYSTEM NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other