BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VSI

    MDR report key: 23485510 · Received November 6, 2025

    Report

    Report Number
    23485510
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    October 9, 2025
    Report Date
    October 15, 2025
    Manufacturer
    TELEFLEX MEDICAL LLC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    DURING CARDIAC CATHETERIZATION, MICROPUNCTURE CATHETER SNAPPED OFF DURING EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2636813 VSI INTRODUCER, CATHETER DYB TELEFLEX MEDICAL LLC 73G2500036

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male