BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILUMIEN¿

    MDR report key: 19159583 · Received April 22, 2024

    Report

    Report Number
    2024168-2024-04955
    Event Type
    Injury
    Date Received
    April 22, 2024
    Date of Event
    April 2, 2024
    Report Date
    August 9, 2024
    Manufacturer
    LIGHTLAB IMAGING, INC.
    Product Code
    NQQ
    PMA / PMN Number
    K210458
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION; HOWEVER, SYSTEM LOGS WERE PROVIDED. A REVIEW OF THE FINISHED PRODUCT DEVICE HISTORY RECORD (DHR) FOR THIS LOT REVEALED NO ASSOCIATED MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT. CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) AND SOFTWARE CHANGE REQUEST (SCR) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. BASED ON THE REPORTED INFORMATION AND RESULTS OF THE COMPLAINT INVESTIGATION, OF THE REPORTED INCORRECT, INADEQUATE OR IMPRECISE RESULT OR READINGS RESULTING IN UNEXPECTED MEDICAL INTERVENTION (NEED FOR AN ADDITIONAL STENT TO TREAT THE DISSECTION) AND MEDICATION REQUIRED (ADMINISTRATION OF NITRATES) IS DUE TO A SOFTWARE BUG. SYSTEM LOGS WERE PROVIDED AND WERE REVIEWED BY SOFTWARE RESEARCH AND DEVELOPMENT, THE REVIEW OF THE SYSTEM LOGS DETERMINED THE ISSUE TO BE A SOFTWARE BUG. SOFTWARE CHANGE REQUEST HAS BEEN CREATED TO ADDRESS THE SOFTWARE BUG. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING, THEREFORE, NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN PULLBACK WAS PERFORMED IN THE LEFT MAIN (LM) AND CIRCUMFLEX (CX) TO ASSESS AN INTERMEDIATE LESION IN THE CX. THE SOFTWARE RECOGNIZED A STENT IN THE CX, WHERE A STENT WAS NOT IMPLANTED. WHILE THE STENT IN THE LM WAS CORRECT (A LM-LAD STENT WAS IMPLANTED), A STENT IN THE CX APPEARED AS WELL. IT SEEMS AS IF THE GUIDEWIRE WAS MISTAKEN FOR A STENT STRUT IN THE CX. FURTHERMORE, THE MINIMAL LUMEN AREA (MLA) SHOWN IN THE LESION WAS AROUND 1.41 MM2, THEREFORE THE PHYSICIAN STENTED THAT LESION WITH A 3.5X23 MM STENT, BASED ON THE INFORMATION GIVEN BY THE OPTICAL COHERENCE TOMOGRAPHY (OCT) RUN (EXTERNAL ELASTIC LAMINA VISIBLE). THE STENT LOOKED OVERSIZED, AND A DISTAL DISSECTION OCCURRED. NITRATES WERE GIVEN WITHOUT IMPROVEMENT; THEREFORE, ANOTHER STENT WAS IMPLANTED IN THE DISTAL CX TO TREAT THE DISSECTION. THE PHYSICIAN FEELS INSECURE AND NOT CONFIDENT WITH THE SOFTWARE FOR OCT GUIDANCE OF PERCUTANEOUS CORONARY INTERVENTION. A SOFTWARE BUG IS SUSPECTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1823471 ILUMIEN¿ ULTRASONIC PULSED ECHO IMAGING SYSTEM NQQ LIGHTLAB IMAGING, INC. C408650 5001156

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention