BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT VASCULAR

    MDR report key: 5519316 · Received March 21, 2016

    Report

    Report Number
    5519316
    Event Type
    Injury
    Date Received
    March 21, 2016
    Date of Event
    March 5, 2016
    Report Date
    March 15, 2016
    Manufacturer
    ABBOTT VASCULAR INTERNATIONAL
    Product Code
    LOX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED INTO CCU FOR CHEST PAIN, AND ST SEGMENT ELEVATION PT WAS TAKEN TO THE CATH LAB WITH THE PLAN TO PLACE AS CORONARY STENT. WHEN PASSING THE BALLOON, THE BALLOON WOULD NOT INFLATE. THIS PRODUCT WAS REMOVED, AND NEW DEVICE OBTAINED, THE SECOND BALLOON DID INFLATE. DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171328 ABBOTT VASCULAR TREK CORONARY DILATION CATH LOX ABBOTT VASCULAR INTERNATIONAL REF 1012272-12 51201G1

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization