BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C8I ¿ OCT INTEGRATED SYSTEM

    MDR report key: 12819311 · Received November 16, 2021

    Report

    Report Number
    3009600098-2021-00019
    Event Type
    Injury
    Date Received
    November 16, 2021
    Date of Event
    October 21, 2021
    Report Date
    February 16, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NQQ
    UDI-DI
    00183739000937
    PMA / PMN Number
    K188320
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE NO COMPONENT WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    DURING THE PROCEDURE, A ONE HOUR DELAY OCCURRED WHEN TWO CATHETERS COULD NOT BE CALIBRATED WITH THE SYSTEM. THE ERROR MESSAGE "PLEASE ADJUST THE CALIBRATION MANUALLY (CAL-002)." APPEARED. THE PROCEDURE WAS COMPLETED WITHOUT OCT AND THE PATIENT WAS STABLE. THE SYSTEM WAS REPAIRED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 0

    DURING THE PROCEDURE, A ONE HOUR DELAY OCCURRED WHEN TWO CATHETERS COULD NOT BE CALIBRATED WITH THE SYSTEM. THE ERROR MESSAGE "PLEASE ADJUST THE CALIBRATION MANUALLY (CAL-002)." APPEARED. THE PROCEDURE WAS COMPLETED WITHOUT OCT AND THE PATIENT WAS STABLE. THE FIBER CONTACTS WERE CLEANED AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719502 C8I ¿ OCT INTEGRATED SYSTEM SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) NQQ ABBOTT VASCULAR C408652 7637699 00183739000937

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization