BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 1884842 · Received October 25, 2010

    Report

    Report Number
    1884842
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 8, 2010
    Manufacturer
    UNK
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD PORT A CATH PLACED ON (B)(6) 2010 FOR CHEMO TREATMENT. ON (B)(6) 2010, CHEMO TREATMENTS COMPLETE AND SURGEON ATTEMPTED TO REMOVE PORT A CATH IN OFFICE. DISTAL PORTION OF PORT A CATH FRACTURED AND REMAINED IN PT. PT THEN SENT TO HOSPITAL FOR RETRIEVAL IN INTERVENTIONAL RADIOLOGY. CATHETER FRACTURED ONCE MORE AT VERY DISTAL END WHILE ATTEMPTING RETRIEVAL. REST OF CATHETER RETRIEVED WITHOUT DIFFICULTY. APPROX 9 CM OF CATHETER FRAGMENT WAS RETRIEVED. ONE TO TWO CENTIMETER CATHETER REMAINS LODGED IN ONE OF THE PULMONARY ARTERIES OF THE LEFT LOWER LOBE. RISK TO RETRIEVE SMALL FRAGMENT OUTWEIGHED THE BENEFITS. UNABLE TO VERIFY MFR, SERIAL NUMBER, LOT NUMBERS, ETC. IF INFO COMES AVAILABLE IN THE FUTURE, WILL PROVIDE IT IN AN ADDENDUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PORT A CATH LJT UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention