BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER

    MDR report key: 10468568 · Received August 28, 2020

    Report

    Report Number
    3005168196-2020-01330
    Event Type
    Injury
    Date Received
    August 28, 2020
    Date of Event
    April 17, 2018
    Report Date
    April 15, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K160449
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 NUMBERS: 3005168196-2020-01325, 3005168196-2020-01326, 3005168196-2020-01327, 3005168196-2020-01328, AND 3005168196-2020-01329.

    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, "THROMBECTOMY FOR ACUTE ISCHEMIC STROKE IN THE ELDERLY: A ''REAL WORLD'' EXPERIENCE." (ALAWIEH ET AL. 2018). IT WAS REPORTED THAT 336 PATIENTS UNDERWENT THROMBECTOMY PROCEDURE USING PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE64), PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER (5MAXC), PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC) AND PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC). ALL DATA WERE COLLECTED FROM A TERTIARY CENTER BETWEEN JANUARY 2013 AND NOVEMBER 2017. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: HEMORRHAGES AND DEATHS. 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
    931214 PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other