BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS

    MDR report key: 6347649 · Received February 10, 2017

    Report

    Report Number
    6347649
    Event Type
    Injury
    Date Received
    February 10, 2017
    Date of Event
    January 25, 2017
    Report Date
    February 7, 2017
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2017, PATIENT GRIMACED WHEN NURSE FLUSHED PORT-A-CATH. IMAGING REVEALED A FRACTURED CENTRAL VENOUS CHEST PORT CATHETER. CHEST PORT WAS PLACED VIA LEFT SUBCLAVIAN VEIN APPROACH IN 2013. PATIENT UNDERWENT AN ENDOVASCULAR RETRIEVAL OF INTRAVASCULAR FOREIGN BODY, CENTRAL VENOUS CHEST PORT CATHETER REMOVAL. A SCOUT RADIOGRAPH DEMONSTRATES FRACTURE OF AN EXISTING LEFT SUBCLAVIAN VEIN APPROACH CENTRAL VENOUS CHEST PORT CATHETER. THE PROXIMAL PORTION OF THE CATHETER REMAINS ATTACHED TO THE CHEST PORT, WITH FRACTURE VISUALIZED AT THE LEVEL OF THE INFERIOR CORTEX OF THE CLAVICLE. THE FREE, DISTAL FRAGMENT OF THE PORT CATHETER COURSES FROM THE LEFT BRACHIOCEPHALIC VEIN TO A RIGHT VENTRICLE. CONCLUSION: SUCCESSFUL ENDOVASCULAR RETRIEVAL OF FRACTURED CHEST PORT CATHETER FRAGMENT. SUCCESSFUL REMOVAL OF LEFT SUBCLAVIAN VEIN APPROACH CHEST PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107234 ANGIODYNAMICS SMALL PORT LJT ANGIODYNAMICS 606289

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention