BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIGULLA FLEX II ASD

    MDR report key: 23356446 · Received October 22, 2025

    Report

    Report Number
    3014616394-2025-00028
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    September 30, 2025
    Report Date
    October 22, 2025
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182521618
    PMA / PMN Number
    P200032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE BATCH RECORD AND INSPECTION PROTOCOLS REVEALED NO DEVIATION. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. FROM THE USER THE FOLLOWING WAS CONCLUDED: IMMEDIATELY PRECEDING DEVICE EMBOLIZATION, ECHOCARDIOGRAPHY DOCUMENTED THAT THE RIGHT ATRIUM WAS DILATING AND THE ATRIAL SEPTUM WAS BOWING INTO THE LEFT ATRIUM. WE SURMISED THAT LIKELY, THE PATIENT HAD LOST THEIR "POP-OFF VALVE" AND THAT BECAUSE OF THE DEGREE OF TRICUSPID REGURGITATION AND PULMONIC INSUFFICIENCY, THE RIGHT ATRIAL PRESSURE MUST HAVE RISEN STRETCHING THE ATRIAL SEPTUM LEADING TO DEVICE EMBOLIZATION. A DEVICE RELATED CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    DEVICE EMBOLIZATION: - PATIENT WITH COMPLICATED CARDIAC HISTORY - ASD12 PLACED; BUT FAILED TUG TEST - ASD12 REPLACED BY ASD16; SUCCESSFUL TUG TEST + DEFECT COMPLETELY CLOSED - DEVICE RELEASE FROM PUSHER AS IT WAS POSITIONED PERFECTLY - SHORTLY AFTER RELEASE DEVICE EMBOLIZED TO LA THEN LV AND SUBSEQUENTLY TO APEX OF ASCENDING AORTA - DEVICE REMOVAL BY MEANS OF SNARE - HEMOSTASIS IN RIGHT GROIN ACHIEVED BY MEANS OF A PERCLOSE DEVICE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229273 FIGULLA FLEX II ASD ASD OCCLUDER OZG OCCLUTECH GMBH 37ASD16 2243371611 04260182521618

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male Life Threatening| R