BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM JETD REPERFUSION CATHETER

    MDR report key: 8591844 · Received May 8, 2019

    Report

    Report Number
    3005168196-2019-00901
    Event Type
    Malfunction
    Date Received
    May 8, 2019
    Date of Event
    April 7, 2019
    Report Date
    April 8, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548019741
    PMA / PMN Number
    K090752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510(K) # THAT ALSO APPLIES TO THIS COMPLAINT: K133317. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    DURING PREPARATION FOR A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM JET D KIT, THE HOSPITAL STAFF NOTICED THE PENUMBRA SYSTEM JET D REPERFUSION CATHETER (JET D) TO BE KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE JET D WAS FOUND PRIOR TO USE, AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER JET D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385609 PENUMBRA SYSTEM JETD REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F86846 00814548019741

    Patients

    Seq Age Sex Outcome Treatment
    1