BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIGULLA FLEX II ASD

    MDR report key: 23347052 · Received October 21, 2025

    Report

    Report Number
    3014616394-2025-00026
    Event Type
    Injury
    Date Received
    October 21, 2025
    Date of Event
    September 12, 2025
    Report Date
    December 11, 2025
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182520697
    PMA / PMN Number
    P200032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TS
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINED ASD OCCLUDER AND FLEX PUSHER WERE RETURNED FOR INVESTIGATIONS. THE OCCLUDER WAS CONNECTABLE TO THE FLEX PUSHER AND WAS WITHSTANDING A TUG TEST. ADDITIONALLY, ALL PARAMETERS WERE WITHIN SPECIFICATION. BASED ON THE AVAILABLE INFORMATION THE ASD OCCLUDER DID NOT CAUSE THE COMPLAINED EVENT.

    Additional Manufacturer Narrative · 0

    BATCH RECORD REVIEW OF THE COMPLAINED ASD OCCLUDER REVEALED NO DEVIATION. NO OTHER COMPLAINT EXISTS FROM THE REPORTED BATCH REGARDING THE SAME COMPLAINT REASON ACCORDING TO THE BATCH RECORD, THE COMPLAINED ASD OCCLUDER PASSED THE VISUAL AND FUNCTIONAL INSPECTION: THE RETRACTION FORCE WAS MEASURED AS 13 N. THE BALL PARAMETERS WITHIN SPECIFICATION: INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    DEVICE EMBOLIZATION: DEVICE EMBOLIZATION OCCURRED DURING POSITIONING AS THE PROSTHESIS DETACHED FROM DELIVERY CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2354677 FIGULLA FLEX II ASD ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD18 2401291805 04260182520697

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Required Intervention| L