BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL PORT VASCULAR ACCESS SYSTEM

    MDR report key: 34111 · Received June 19, 1996

    Report

    Report Number
    34111
    Event Type
    Injury
    Date Received
    June 19, 1996
    Date of Event
    June 5, 1996
    Report Date
    June 14, 1996
    Manufacturer
    CARBOMEDICS, INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 41-YR-OLD FEMALE PT HAD A PORT SURGICALLY IMPLANTED 4/18/96 TO FACILITATE CHEMOTHERAPY. SHE RETURNED ON 6/5/96 FOR EVALUATION OF THE CATHETER WHICH WAS NON-FUNCTIONING, AND SUSPECTED TO BE THROMBOSED. A VENOGRAM STUDY SHOWED THE CATHETER WAS SHEARED OFF APPROX 4 CM FROM THE HUB. THE DISTAL SEGMENT WAS LOCATED IN SUPERIOR VENA CAVA, EXTENDING INTO THE RIGHT ATRIUM. IT WAS RETRIEVED PERCUTANEOUSLY VIA THE RIGHT FEMORAL VEIN WITH CT GUIDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL PORT VASCULAR ACCESS SYSTEM Implant IMPLANTABLE INFUSION DEVICE LJT CARBOMEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention