BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILUMIEN OPTIS SYSTEM

    MDR report key: 11095630 · Received December 30, 2020

    Report

    Report Number
    3009600098-2020-00029
    Event Type
    Injury
    Date Received
    December 30, 2020
    Date of Event
    December 4, 2020
    Report Date
    March 18, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NQQ
    UDI-DI
    00183739000678
    PMA / PMN Number
    K188320
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO COMPONENT WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS NOT REVIEWED AS A MANUFACTURING/DESIGN ISSUE IS NOT SUSPECTED AS THE DEVICE WAS MANUFACTURED IN 2017. THEREFORE, IT HAS EXCEEDED ITS DESIGN SERVICE LIFE EXPECTANCY OF TWO YEARS. THERE ARE NO SUSPECTED MANUFACTURING/DESIGN/NCMR/CAPA RELATED ISSUES TO REFERENCE AS A ROOT CAUSE COULD NOT BE DETERMINED. THERE ARE NO PRIOR RELATED COMPLAINTS AGAINST THIS SYSTEM AND IT HAS NOT BEEN RETURNED IN THE PAST FOR REFURBISHMENT. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. NO CORRECTIVE ACTION NEEDED AS THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    RELATED MANUFACTURING REF: 2184149-2020-00241, 2184149-2020-00240. DURING THE PROCEDURE, A SIGNIFICANT DELAY OCCURRED. THE START UP OF THE SYSTEM WAS SIGNIFICANTLY PROLONGED AND "FFR RECEIVER FAULT DETECT" WAS DISPLAYED AFTER STARTUP. THE CONNECTION BETWEEN THE CATHETER AND THE DOC FAILED AND IT TOOK TWO TO THREE TIMES TO CONNECT SUCCESSFULLY. AFTER DETECTION THE IMAGING EFFECT WAS NOT GOOD, THE BRIGHTNESS AND CONTRAST WERE NOT HIGH, AND THE NATURE OF THE PLAQUE COULD NOT BE SEEN CLEARLY. THE PROCEDURE WAS COMPLETED WITH THE SAME SYSTEM WITH NO ADVERSE PATIENT CONSEQUENCES. THE FFR RECEIVERS AND OPTICAL ADAPTER WERE REPLACED TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561163 ILUMIEN OPTIS SYSTEM SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) NQQ ABBOTT VASCULAR C408650 5925133 00183739000678

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AO USB RECEIVER| PW USB RECEIVER| AO USB RECEIVER| PW USB RECEIVER