BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER

    MDR report key: 11803024 · Received May 10, 2021

    Report

    Report Number
    3005168196-2021-01006
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    March 1, 2010
    Report Date
    April 15, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K160449
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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, DISTAL EMBOLIZATION, INTRACRANIAL HEMORRHAGE, VESSEL SPASM, DISSECTION, INABILITY TO COMPLETELY REMOVE THROMBUS, THROMBOSIS, ISCHEMIA, INCLUDING DEATH. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 3005168196-2021-01004, 3005168196-2021-01005.

    Description of Event or Problem · 1

    DURING ITS POST-MARKET SURVEILLANCE ACTIVITIES ON (B)(6) 2021, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, (B)(6)). THIS ARTICLE INCLUDES THE CLINICAL ANALYSIS OF FORTY-SIX PATIENTS FROM THREE STROKE CENTERS BETWEEN (B)(6) 2010 AND (B)(6) 2016 WHO UNDERWENT PROCEDURES IN THE BASILAR ARTERY UTILIZING THE DIRECT ASPIRATION FIRST PASS TECHNIQUE (ADAPT). IT WAS REPORTED THAT ASPIRATION WAS PERFORMED MOSTLY WITH A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60); HOWEVER, EIGHT PROCEDURES UTILIZED A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER (5MAXC), ONE PROCEDURE UTILIZED A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), AND TWO PROCEDURES UTILIZED A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER (ACE64). REPORTED PROCEDURAL COMPLICATIONS INCLUDED ONE NEW-TERRITORY EMBOLIC EVENT, ONE VESSEL PERFORATION, AND TWO PARENCHYMAL HEMATOMAS TYPE 1. IT WAS NOT SPECIFIED WHICH PENUMBRA CATHETER WAS BEING USED WHEN THE EVENTS OCCURRED, NOR THE RELATIONSHIP BETWEEN THE PENUMBRA CATHETER AND THE RESPECTIVE PROCEDURAL COMPLICATIONS. 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
    699203 PENUMBRA SYSTEM REPERFUSION CATHETER NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1