BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGRAPHIC GUIDEWIRE, FIXED CORE, J TIP

    MDR report key: 11752094 · Received April 30, 2021

    Report

    Report Number
    11752094
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 21, 2021
    Report Date
    April 26, 2021
    Manufacturer
    NAVILYST MEDICAL, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NAMIC J-WIRE THAT COMES IN THE LEFT HEART CONVENIENCE KIT WAS INSERTED IN THE GUIDE CATHETER INTACT, AND WHEN THE WIRE WAS REMOVED AFTER OBTAINING ACCESS TO THE LEFT CORONARY ARTERY, IT WAS FOUND THAT THE WIRE WAS BROKEN AT THE DISTAL TIP AND PART OF THE INNER CORE WAS VISIBLE. NO PART OF THE WIRE WAS LEFT INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654065 ANGIOGRAPHIC GUIDEWIRE, FIXED CORE, J TIP WIRE, GUIDE, CATHETER DQX NAVILYST MEDICAL, INC. 97000202 GFER2257

    Patients

    Seq Age Sex Outcome Treatment
    1 33215 DA