BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIGULLA FLEX II ASD

    MDR report key: 23035281 · Received September 12, 2025

    Report

    Report Number
    3014616394-2025-00018
    Event Type
    Injury
    Date Received
    September 12, 2025
    Date of Event
    August 29, 2025
    Report Date
    September 12, 2025
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182521564
    PMA / PMN Number
    P200032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOT ALL PATIENT INFORMATION IS AVAILABLE. IT WAS STATED BY THE ATTENDING PHYSICIAN: THE SELECTED DEVICE SIZE WAS TOO SMALL. THAT CAUSED THE DEVICE DISLOCATION / EMBOLIZATION. DURING THE FIRST PROCEDURE THE DEFECT SIZE WAS MEASURED UNDER ICE ONLY. NO DEFECT SIZING BY MEANS OF A SIZING BALLOON WAS DONE BY THE USER. DURING THE SECOND PROCEDURE THE DEFECT WAS MEASURED WITH A SIZING BALLOON WHICH REVEALED A LARGER SIZE AS MEASURED BEFORE DURING THE FIRST PROCEDURE BY MEANS OF ICE. MANUFACTURER CONCLUSION: MEASURMENT UNDER ICE SOMETIMES CAN CAUSE UNDERESTIMATATION OF THE DEFECT SIZE. THEREFORE, IT IS NECESSARY TO ALSO MEASURE AND CONFIRM THE DEFECT SIZE BY MEANS OF SIZING BALLOON. THE EVENT WAS CAUSED BY A USER ERROR. PROBLEMS TRACED TO THE USER NOT FOLLOWING THE MANUFACTURER'S INSTRUCTIONS.

    Description of Event or Problem · 0

    THE ASD MEASURED ABOUT 6MM AT STATIC MEASUREMENT UNDER ICE IMAGING. NO BALLOON SIZING WAS PERFORMED. 9MM WAS IMPLANTED AND PROCEDURE WAS COMPLETE. LATER THAT DAY, ECHO/CXR SHOWED THE DEVICE WAS EMBOLIZED TO THE DESCENDING AORTA. PATIENT WAS TAKEN BACK TO THE LAB AND THE DEVICE WAS REMOVED SUCCESSFULLY AND GORE SEPTAL OCCLUDER WAS IMPLANTED UNDER ICE. BALLOON SIZING WAS USED FOR THE IMPLANTATION OF THE GORE DEVICE AND THE PATIENT WENT HOME AND IS DOING WELL. DR. (B)(6) SAID, THE OCCLUTECH DEVICE WAS UNDERSIZED AND REASON FOR EMBOLIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2676546 FIGULLA FLEX II ASD ASD OCCLUDER OZG OCCLUTECH GMBH 37ASD09P 2303370902 04260182521564

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| L