BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IG4 SYSTEM, 120V, 60HZ

    MDR report key: 17278847 · Received July 7, 2023

    Report

    Report Number
    3007222345-2023-00076
    Event Type
    Injury
    Date Received
    July 7, 2023
    Report Date
    July 7, 2023
    Manufacturer
    VERAN MEDICAL TECHNOLOGIES, INC.
    Product Code
    JAK
    UDI-DI
    00815686020088
    PMA / PMN Number
    K122106
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT - PROCEDURES WERE PERFORMED BETWEEN JUNE 2015 AND APRIL 2017. THE JOURNAL ARTICLE REFERS TO A "SPINDRIVE TIP TRACKED INSTRUMENT EMN SYSTEM". BASED ON THE TIMING OF THE DESCRIBED EVENTS, IT IS LIKELY THE DEVICE WAS AN SYS-3000 IG4 SYSTEM, 120V, 60HZ. PNEUMOTHORAX AND BLEEDING ARE KNOWN RISKS OF THE DEVICE AND THE ASSOCIATED PROCEDURE(S). PLEASE REFER TO THE JOURNAL ARTICLE ATTACHED TO THIS SUBMISSION.

    Description of Event or Problem · 0

    JOURNAL ARTICLE: PERIPHERAL LUNG NODULE DIAGNOSIS AND FIDUCIAL MARKER PLACEMENT USING A NOVEL TIP-TRACKED ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY SYSTEM. PUBLISHED JANUARY 2019. BACKGROUND: ELECTROMAGNETIC NAVIGATION (EMN) HAS IMPROVED BRONCHOSCOPIC ACCESS TO PERIPHERAL PULMONARY NODULES. A NOVEL EMN SYSTEM UTILIZING NOVEL TIP-TRACKED INSTRUMENTS FOR ENDOBRONCHIAL [ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB)] AS WELL AS TRANSTHORACIC LUNG BIOPSY [ELECTROMAGNETIC-GUIDED TRANSTHORACIC NEEDLE ASPIRATION (EMTTNA)] HAS BECOME AVAILABLE. THE SYSTEM PROVIDES REAL-TIME FEEDBACK AS WELL AS THE ABILITY TO BIOPSY LESIONS OUTSIDE OF THE AIRWAY. THESE ADVANCES HAVE THE POTENTIAL TO IMPROVE DIAGNOSTIC YIELD OVER PREVIOUS EMN SYSTEMS. BASED ON THE ARTICLE, THERE WERE FOUR (4) ADVERSE EVENTS DOCUMENTED: - THERE WERE THREE (3) PATIENTS THAT DEVELOPED A PNEUMOTHORAX THAT REQUIRED SMALL-BORE CHEST TUBE PLACEMENT WITH AN OBSERVATION ADMISSION (<24 HOURS). - THERE WAS ONE (1) PATIENT THAT DEVELOPED A HEMORRHAGE THAT REQUIRED BRONCHOSCOPIC WEDGING AND ICED SALINE TO ACHIEVE HEMOSTASIS. THE PATIENT WAS SUBSEQUENTLY DISCHARGED HOME. THERE WAS NO ALLEGATION OR INFORMATION TO SUGGEST THERE WAS AN ASSOCIATED MALFUNCTION OF A VERAN DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014422 IG4 SYSTEM, 120V, 60HZ NAVIGATION SYSTEM JAK VERAN MEDICAL TECHNOLOGIES, INC. SYS-3000 00815686020088

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R