BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COUGAR

    MDR report key: 4482181 · Received December 8, 2014

    Report

    Report Number
    4482181
    Event Type
    Malfunction
    Date Received
    December 8, 2014
    Date of Event
    December 4, 2014
    Report Date
    December 8, 2014
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    COUGAR LS CORONARY WIRE HAD A DEFECT ON IT THAT WOULD NOT ALLOW A CORONARY BALLOON TO CROSS IT. A NEW WIRE WAS RETREIVED AND THE PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792611 COUGAR WIRE, GUIDE, CATHETER DQX MEDTRONIC VASCULAR * G14A05753

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR