BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 1209164 · Received October 16, 2008

    Report

    Report Number
    1056436-2008-00045
    Event Type
    Death
    Date Received
    October 16, 2008
    Date of Event
    August 22, 2008
    Report Date
    October 16, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED LOOSE SEGMENT OF CATHETER WAS EVALUATED, AND REVEALED AT THE PROXIMAL END DAMAGES CONSISTENT WITH IRREGULAR TEARING, LUMINAL NARROWING, LONGITUDE SLIT AND COMPRESSION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND REVEALED NO MANUFACTURING VARIANCES RELATED TO THIS EVENT. THE COMPLAINT WAS CONFIRMED. THE DAMAGES REVEALED TO THE LOOSE SEGMENT OF DEVICE CATHETER APPEAR CONSISTENT WITH CATHETER SHEAR CAUSED BY "PINCH-OFF SYNDROME".

    Description of Event or Problem · 1

    PATIENT WENT IN FOR CHEMO, AND NURSES COULD NOT GET A BLOOD RETURN. PT SENT FOR X-RAY, AND IT WAS DISCOVERED THAT THE TIP OF THE CATHETER HAD MIGRATED TO PULMONARY ARTERY. PT SENT FOR RETRIEVAL, DURING RETRIEVAL, PT BECAME BRIEFLY UNRESPONSIVE, BUT QUICKLY CAME TO RESPONSIVENESS. SUCCESSFUL RETRIEVAL OF CATHETER TIP. PT SENT TO ICU AFTER RETRIEVAL, BUT OUTCOME WAS POOR AND PT DIED. ADDITIONAL INFO FROM RISK MANAGEMENT, MEDICAL EXAMINER DISCARDED OF THE PORT DURING AUTOPSY OF PT. RISK MANAGEMENT RETAINED 10.2CM SECTION OF CATHETER THAT WAS RETRIEVED FROM PT, AND IS WILLING TO SEND THE PRODUCT BACK. REQUESTED AUTOPSY RESULTS FOR CAUSE OF DEATH, BUT USER FACILITY HAS NOT RELEASED THIS DOCUMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT VASCULAR ACCESS SYSTEM VASCULAR ACCESS PORT LJT ANGIODYNAMICS, INC. NA 30932

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death| R