BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-VU ANGIOGRAPHIC CATHETER

    MDR report key: 2003532 · Received February 18, 2011

    Report

    Report Number
    MW5019518
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 18, 2011
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STERILE DISPOSABLE SUPPLY (PIGTAIL) BEING USED DURING ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (AAA). DISTAL TIP OF PIGTAIL CATHETER FRACTURED AND WAS UNABLE TO BE RETRIEVED. DISTAL CATHETER TIP WAS LEFT IN ANEURYSM SAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-VU ANGIOGRAPHIC CATHETER SIZING PIGTAIL -NON-BRAIDED- DQO ANGIODYNAMICS, INC. 524891

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other