BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA, INC. HEART CATH WIRE

    MDR report key: 17735371 · Received September 12, 2023

    Report

    Report Number
    MW5145558
    Event Type
    Malfunction
    Date Received
    September 12, 2023
    Date of Event
    August 25, 2023
    Report Date
    September 7, 2023
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TECH NOTED A SMALL HOLE IN WIRE WHEN FLUSHING AND NOTICED FLUID LEAKING WIRES CAN BE EASILY BENT/KINKED DURING DIFFICULT OR CHALLENGING INSERTION, BUT SHOULD NOT HAVE PERFORATION IN INTEGRITY OF WALL (2ND WIRE USED ON THIS PATIENT WITH SAME ISSUE). REFERENCE REPORT MW5145559. REFER TO ADD'L DOCUMENTS IN I2K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303791 PENUMBRA, INC. HEART CATH WIRE CORONARY MECHANICAL THROMBECTOMY WITH ASPIRATION QEW PENUMBRA, INC. F00005565

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male