BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDIS

    MDR report key: 17134811 · Received June 15, 2023

    Report

    Report Number
    17134811
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    May 19, 2023
    Report Date
    May 22, 2023
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQY
    UDI-DI
    20705032020036
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ELDERLY FEMALE WITH HISTORY OF TYPE 1 DB (DIABETES), CAD (CORONARY ARTERY DISEASE) AND RECENT SOB (SHORTNESS OF BREATH) AND EDEMA. PROCEDURE: DIAGNOSTIC HEART CATH AND PCI (PERCUTANEOUS CORONARY INTERVENTION). 2 KINKS WERE VISUALIZED IN THE CORDIS, VISTA BRITETIP CATHETER. NOT USED ON PATIENT.

    Description of Event or Problem · 0

    ELDERLY FEMALE WITH HISTORY OF TYPE 1 DB (DIABETES), CAD (CORONARY ARTERY DISEASE) AND RECENT SOB (SHORTNESS OF BREATH) AND EDEMA. PROCEDURE: DIAGNOSTIC HEART CATH AND PCI (PERCUTANEOUS CORONARY INTERVENTION). 2 KINKS WERE VISUALIZED IN THE CORDIS, VISTA BRITETIP CATHETER. NOT USED ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229952 CORDIS CATHETER, PERCUTANEOUS DQY CORDIS CORPORATION 67003400 18190419 20705032020036

    Patients

    Seq Age Sex Outcome Treatment
    1 27010 DA Female