BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST. JUDE AGILIS NXT

    MDR report key: 3874227 · Received June 11, 2014

    Report

    Report Number
    MW5036607
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 5, 2014
    Manufacturer
    ST. JUDE
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AGILIS HANDLE BECAME UNATTACHED FORM BODY OF SHEATH WHILE PHYSICIAN WAS STEERING/TURNING HANDLE. HANDLE STAYED ON SHEATH. EXCHANGED SHEATH OVER WIRE TO A NEW AGILIS. NO HARM WAS CAUSED TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343863 ST. JUDE AGILIS NXT SHEATH DYB ST. JUDE 408309 4452992

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR