BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT TREK-VASCULAR

    MDR report key: 6185822 · Received December 13, 2016

    Report

    Report Number
    MW5066772
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    December 7, 2016
    Report Date
    December 13, 2016
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    LOX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BALLOON CATHETER BROKE IN LEFT MAIN ARTERY. ALL WAS REMOVED FROM PT BUT THE SHEATH NEEDED TO BE REMOVED IMMEDIATELY TO DISLODGE THE BROKEN CATHETER AND BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819824 ABBOTT TREK-VASCULAR BALLOON CATHETER CORONARY DILATATION LOX ABBOTT VASCULAR 1012455-1-2 50914G1

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR