BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 22847757 · Received August 20, 2025

    Report

    Report Number
    3014616394-2025-00014
    Event Type
    Injury
    Date Received
    August 20, 2025
    Date of Event
    July 3, 2025
    Report Date
    January 16, 2025
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182520727
    PMA / PMN Number
    P200032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE BATCH RECORD AND INSPECTION PROTOCOLS OF THE REPORTED DEVICE REVEALED NO DEVIATION. ALL QC CRITERIA WERE WITHIN SPECIFICATION ACCORDING TO THE BATCH RECORD. THE STORAGE CONDITIONS WERE WITHIN THE SPECIFIED PARAMETERS. BASED ON THE FACT THAT THE DEVICE WAS TESTED PRIOR TO IMPLANTATION AND SHOWED A DEVIATION, THE DEVICE SHOUD NOT BE IMPLANTED. (SEE IFU 5.1.) AND THE DEFECT SIZE BEING TOO SMALL FOR 29ASD27 HAD A SIGNIFICANT INFLUENCE ON THE SHAPE DEVELOPMENT OF THE OCCLUDER. THE EXACT CAUSE OF THE MALFORMATION CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE BATCH RECORD AND INSPECTION PROTOCOLS OF THE REPORTED DEVICE REVEALED NO DEVIATION. ALL QC CRITERIA WERE WITHIN SPECIFICATION ACCORDING TO THE BATCH RECORD. THE STORAGE CONDITIONS WERE WITHIN THE SPECIFIED PARAMETERS. THE FINAL INSPECTION OF THE REPORTED DEVICE AND ITS CORRESPONDING PROCEDURE PACK REVEALED NO DEVIATIONS.

    Description of Event or Problem · 0

    A FAILURE IN SHAPE DEVELOPMENT OF THE OCCLUDER BOTH ON TABLE AND IN THE PATIENT WAS REPORTED.

    Description of Event or Problem · 0

    A FAILURE IN SHAPE DEVELOPMENT OF THE OCCLUDER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155437 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD27 2428292701 04260182520727

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Hospitalization