BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDING CATHETER - MANSFIELD

    MDR report key: 34917 · Received July 22, 1996

    Report

    Report Number
    34917
    Event Type
    Malfunction
    Date Received
    July 22, 1996
    Date of Event
    July 3, 1996
    Report Date
    July 18, 1996
    Manufacturer
    SCIMED LIFE SYSTEMS, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT S/P ANTERIOR WALL MI - HAVING A CORONARY ANGIOGRAM AND PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. GUIDING CATHETER WAS INSERTED INTO THE AORTA TOWARD LEFT CORONARY ARTERY. APPROX 1MM FRAGMENT WAS NOTED MISSING FROM TIP OF CATHETER - LODGED IN A VERY SMALL BRANCH IN CIRCUMFLEX SYSTEM (SEEN ON FLUOROSCOPY) - PT ASYMPTOMATIC, FRAGMENT APPEARS LODGED SECURELY. MD DOES NOT ANTICIPATE ANY PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDING CATHETER - MANSFIELD 8FR PERFORMER XL ALI DYB SCIMED LIFE SYSTEMS, INC. 4450

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR