BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RING DRAINAGE CATHETER NEEDLE SET

    MDR report key: 2478431 · Received February 13, 2012

    Report

    Report Number
    2478431
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Date of Event
    February 7, 2012
    Report Date
    February 13, 2012
    Manufacturer
    COOK MEDICAL
    Product Code
    DWO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS IN INTERVENTIONAL RADIOLOGY FOR EMBOLIZATION OF AN ABDOMINAL AORTIC ANEURYSM (AAA) ENDO LEAK. AFTER MULTIPLE ATTEMPTS THE CATHETER FRACTURED AND 10 CM OF CATHETER WAS LEFT IN THE PATIENT. ATTEMPTS TO RETRIEVE THE RETAINED CATHETER WERE UNSUCCESSFUL. THE PATIENT HAS HAD NO ADVERSE OUTCOMES TO DATE AND CONTINUES TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RING DRAINAGE CATHETER NEEDLE SET NEEDLE, BIOPSY, CARDIOVASCULAR DWO COOK MEDICAL DLPN-40-25-RING 2543138

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR