BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT-VU ANGIOGRAPHIC CATHETER

    MDR report key: 2211219 · Received July 12, 2011

    Report

    Report Number
    1319211-2011-00066
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DQO
    PMA / PMN Number
    K9141999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH IT WAS INDICATED THAT THE REPORTED DEFECTIVE DEVICE IS AVAILABLE FOR EVAL, IT HAS YET TO BE RECEIVED BY THE MFR. AN INVESTIGATION INTO THE ROOT CAUSE FOR INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH.

    Description of Event or Problem · 1

    DURING A PTC AND STENTING, THE TIP OF THE CATHETER BECAME DETACHED FROM THE CATHETER SHAFT AND IS LODGED IN THE LIVER. IT IS REPORTED BY THE USER THAT THE PT IS IN PALLIATIVE CARE AND DOES NOT WANT THE TIP REMOVED. THE USER REPORTED THAT THE DETACHED TIP IS NOT CAUSING THE PT ANY ADVERSE ISSUES. THE CATALOG NUMBER AND LOT NUMBER WERE NOT REPORTED AS THE PACKAGING AND LABELING OF THIS DEVICE WERE DISCARDED. THE USER NOTED THAT THE CATHETER WAS POSSIBLY EXPIRED WHEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFT-VU ANGIOGRAPHIC CATHETER ANGIOGRAPHIC CATHETER DQO ANGIODYNAMICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1