BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM JET7 REPERFUSION CATHETER

    MDR report key: 11773787 · Received May 4, 2021

    Report

    Report Number
    3005168196-2021-00959
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    September 1, 2018
    Report Date
    April 7, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K173761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2021-00958.

    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 ANALYZES A TOTAL OF ONE-HUNDRED AND FORTY-FIVE THROMBECTOMY PROCEDURES PERFORMED BETWEEN (B)(6) 2018 AND (B)(6) 2019 EXTRACTED FROM A PROSPECTIVELY MAINTAINED DATABASE. IT WAS REPORTED THAT THE PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7) WAS USED IN NINE PROCEDURES TO COMPLETE THE FIRST PASS. IT WAS REPORTED THAT THE JET7 WOULD NOT TRACK AROUND THE CAROTID SIPHON IN TWO CASES. THEREFORE, AN ALTERNATIVE ASPIRATION CATHETER WAS USED TO TRACK TO THE CLOT IN THESE TWO CASES, RESPECTIVELY. 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
    667921 PENUMBRA SYSTEM JET7 REPERFUSION CATHETER NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1