BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT

    MDR report key: 113850 · Received August 14, 1997

    Report

    Report Number
    113850
    Event Type
    Injury
    Date Received
    August 14, 1997
    Date of Event
    August 6, 1997
    Report Date
    August 12, 1997
    Manufacturer
    STRATO MEDICAL CORP
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON REMOVAL OF LIFEPORT VASCULAR ACCESS DEVICE, SEVERAL CENTIMETERS OF THE DISTAL CATHETER HAD SHEARED OFF AND WAS LODGED IN THE ATRIA OF THE PT'S HEART. PT WAS TRANSFERRED TO A UNIVERSITY HOSP FOR DISPOSITION. PT ASYMPTOMATIC AT TIME OF TRANSFER TO UNIV HOSP. LIFEPORT DEVICE SENT WITH PT TO UNIV HOSP TO ENSURE ENTIRE CATHETER RETRIEVAL AS PER SURGEON'S INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT Implant VASCULAR ACCESS SYSTEM LJT STRATO MEDICAL CORP * 12822

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention