BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PT GRAPHIX

    MDR report key: 8645240 · Received May 28, 2019

    Report

    Report Number
    8645240
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    April 17, 2019
    Report Date
    May 13, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE PT GRAPHIX BROKE OFF AND BECAME STUCK IN THE PATIENT STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440364 PT GRAPHIX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION 23355508

    Patients

    Seq Age Sex Outcome Treatment
    1 24090 DA