BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL PORT

    MDR report key: 20455 · Received February 7, 1995

    Report

    Report Number
    20455
    Event Type
    Injury
    Date Received
    February 7, 1995
    Date of Event
    January 3, 1995
    Report Date
    January 26, 1995
    Manufacturer
    COOK PACEMAKER CORP.
    Product Code
    LJT
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PORT WAS IMPLANTED ON 12/13/93 FOR CHEMOTHERAPY ADMINISTRATION. SURGEON WAS CONSULTED ON 1/3/95 DUE TO MALFUNCTIONING (LEAKING) PORT. WHEN SURGEON ATTEMPTED TO REMOVE PORT, ONLY 2-3 INCH LENGTH CAME OUT. SUBSEQUENT RADIOLOGIST'S RE-READ OF A 12/31/94 CHEST X-RAY CONFIRMED THAT CATHETER WAS BROKEN, WITH THE DISTAL PORTION LYING IN THE RIGHT ATRIUM. REMAINING CATHETER PIECE WAS REMOVED BY HEART CATHETERIZATION OF 1/4/95.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL PORT Implant VASCULAR ACCESS PORT LJT COOK PACEMAKER CORP. 1PH9112

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention