BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL STENT-FIRM 6X26

    MDR report key: 5038573 · Received August 24, 2015

    Report

    Report Number
    MW5055802
    Event Type
    Malfunction
    Date Received
    August 24, 2015
    Date of Event
    August 20, 2015
    Report Date
    August 24, 2015
    Manufacturer
    COOK MEDICAL
    Product Code
    FEW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    UNIVERSAL STENT-FIRM 6X26, WHILE UNDER FLUOROSCOPY (NO SCOPE), THE MONOFILAMENT WIRE BROKE WHILE WITHIN THE PATIENT. WIRE HAD TO BE PULLED AND REMOVED IN FOUR DIFFERENT PIECES AS IT CONTINUED TO UNRAVEL. CASE TIME WAS INCREASED BY 10 MINUTES DURING THIS PROCESS OF SEARCHING AND REMOVING THE PIECES FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558626 UNIVERSAL STENT-FIRM 6X26 UNIVERSAL STENT-FIRM 6X26 FEW COOK MEDICAL G23406 5942162

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR