BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC TRECK 4.5

    MDR report key: 4269643 · Received November 5, 2014

    Report

    Report Number
    MW5039123
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    September 29, 2014
    Report Date
    November 3, 2014
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STENT WAS DEPLOYED AND AFTER OTHER DIFFICULTIES, BALLOON REMAINED IN RIGHT CORONARY ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710340 NC TRECK 4.5 CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR 110126A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention