BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2180607 · Received July 12, 2011

    Report

    Report Number
    2180607
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    August 27, 2010
    Report Date
    July 12, 2011
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A PORT PLACEMENT FOR CHEMOTHERAPY TREATMENTS. DURING THE PROCEDURE, AT SOME POINT THE GUIDE WIRE SHEARED LEAVING A 17 CM PIECE OF GUIDE WIRE IN THE PATIENT. THE SHEARED PORTION OF THE GUIDE WIRE WAS NOT RECOGNIZED AT THE TIME OR ON THE CHEST X-RAY POSTOPERATIVELY. IT WAS NOT UNTIL A SUBSEQUENT CT SCAN THAT THE GUIDE WIRE PORTION WAS DETECTED. THE PATIENT RETURNED SHORTLY AFTER THE IDENTIFICATION OF THE FOREIGN BODY FOR A SUCCESSFUL RETRIEVAL IN INTERVENTIONAL RADIOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CATHETER, PORT, IMPLANTED LJT BARD ACCESS SYSTEMS * REUF0420

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR NO OTHER THERAPIES