BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENTSON

    MDR report key: 4852692 · Received May 21, 2015

    Report

    Report Number
    4852692
    Event Type
    Malfunction
    Date Received
    May 21, 2015
    Date of Event
    March 11, 2015
    Report Date
    April 7, 2015
    Manufacturer
    COOK, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    WHILE PASSING THE WIRE GUIDE, THE SURGEON NOTED AN AREA WHERE THE WIRE WAS BENT/FLACCID AND WAS UNABLE TO DEPLOY THE STENT.======================MANUFACTURER RESPONSE FOR DISPOSABLE GUIDE WIRE, BENTSON PTFE WIRE GUIDE (PER SITE REPORTER).======================THEY ASKED FOR THE WIRE TO BE SENT TO THEM FOR EVALUATION. THERE WAS NOT ANY HARM SO WE CAN RELEASE THE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333937 BENTSON WIRE, GUIDE, CATHETER DQX COOK, INC. G14590 5335112

    Patients

    Seq Age Sex Outcome Treatment
    1 *