BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT A CATH

    MDR report key: 471241 · Received July 11, 2003

    Report

    Report Number
    471241
    Event Type
    Injury
    Date Received
    July 11, 2003
    Report Date
    July 11, 2003
    Manufacturer
    DELTEC
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PORT-A-CATH INSERTED WITHOUT INCIDENT. CHEST X-RAY NORMAL AFTERWARDS. CATH BEGAN LEAKING. A REPEAT CHEST X-RAY SHOWED CATH HAD FRACTURED AND THAT A 3 INCH PIECE OF IT WAS LODGED IN PT'S HEART, IN THE RIGHT ATRIUM, REQUIRED SURGICAL INTERVENTION TO RETRIEVE THE BROKEN PIECE FROM THE HEART. THE INTERVENTION TOOK PLACE VIA ENDOVASCULAR APPROACH, THE PROCEDURE WAS SUCCESSFUL, AND THE PT DOES NOT APPEAR TO HAVE SUFFERED ANY SEQUELAE BECAUSE OF IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORT A CATH INDWELLING VENOUS CATHETER LJT DELTEC REF 21-4053-24 98766

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention