BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIS NXT

    MDR report key: 6689246 · Received July 6, 2017

    Report

    Report Number
    6689246
    Event Type
    Malfunction
    Date Received
    July 6, 2017
    Date of Event
    June 2, 2017
    Report Date
    June 21, 2017
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SHEATH WAS IN THE BODY AND THE STEERING MECHANISM STOPPED WORKING. IT WAS EXCHANGED FOR A NEW ONE WITH NO FURTHER ISSUES. NO HARM WAS DONE TO THE PATIENT. AGILIS 8.5 FR SHEATH, REF (B)(4), LOT 5810860, EXP 12/31/2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472090 AGILIS NXT INTRODUCER, CATHETER DYB ST. JUDE MEDICAL 8.5 FR SHEATH 5810860

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR NOT KNOWN.| UNKNOWN.