BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSENSE WEBSTER

    MDR report key: 9397167 · Received December 2, 2019

    Report

    Report Number
    9397167
    Event Type
    Injury
    Date Received
    December 2, 2019
    Date of Event
    September 13, 2019
    Report Date
    November 27, 2019
    Product Code
    MTD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE EKG CHANGES NOTED, AIR EMBOLUS IN CORONARY ARTERIES; PT UNDERWENT CARDIAC CATH. FLUID INFUSING PER PRESSURE BAG DEVICE WITH AIR BUBBLES NOTED IN LINE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193459 BIOSENSE WEBSTER PENTA RAY MAPPING CATHETER MTD 30242586L

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention