BEUDAMED
    FDA Adverse Event Other Summary report: N

    WIRE, GUIDE, CATHETER

    MDR report key: 17905832 · Received October 6, 2023

    Report

    Report Number
    MW5146757
    Event Type
    Other
    Date Received
    October 6, 2023
    Report Date
    September 14, 2023
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    DQX
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    INCOMING INFORMATION REPORTED THAT THE PATIENT SUFFERED AN SUPERIOR VENA CAVA (SVC) DISSECTION WITH AN ANGIODYNAMIC J WIRE DURING AN ATTEMPTED IMPLANT. A CHEST TUBE WAS INSERTED INTO THE PATIENT ACCORDINGLY. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2237480 WIRE, GUIDE, CATHETER WIRE, GUIDE, CATHETER DQX ANGIODYNAMICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown