BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 23473987 · Received November 5, 2025

    Report

    Report Number
    3014616394-2025-00029
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    October 2, 2025
    Report Date
    December 10, 2025
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182521564
    PMA / PMN Number
    P200032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE BATCH RECORD AND INSPECTION PROTOCOLS REVEALED NO DEVIATION. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE CORRESPONDING IFU COVERS ALL WARNING AND PREVENTIVE MEASURES TO AVOID THE OCCURRENCE OF EMBOLIZATION EVENTS. NEVERTHELESS, "EMBOLIZATION (PERI & POST PROCEDURAL)" IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE IFU. THE FOLLOWING STATEMENT FROM THE CUSTOMER WAS ALSO CONSIDERED FOR THE INVESTIGATION CONCLUSION: "APPROXIMATELY 24 HOURS AFTER IMPLANTING THE DEVICE, IT CAME LOOSE FROM ONE SIDE OF THE SEPTUM AND WAS THEN REMOVED VIA SURGERY. THIS WAS NOT A FAILURE OF THE DEVICE."IN THE LIGHT OF ALL INVESTIGATION FINDINGS, NO DEVICE RELATED ROOT CAUSE COULD BE IDENTIFIED. THE ROOT CAUSE WAS TRACED BACK TO NON-DEVICE RELATED FACTORS.

    Additional Manufacturer Narrative · 0

    THE REVIEW OF THE BATCH RECORD AND INSPECTION PROTOCOLS OF THE REPORTED DEVICE REVEALED NO DEVIATION. NO OTHER COMPLAINT EXISTS FROM THE REPORTED LOT REGARDING THE SAME COMPLAINT REASON. ALL QC CRITERIA WERE WITHIN SPECIFICATION ACCORDING TO THE BATCH RECORD. A1-A4 IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATLY 24 HOURS AFTER IMPLANTING THE DEVICE, IT CAME LOOSE FROM ONE SIDE OF THE SEPTUM AND WAS THEN REMOVED VIA SURGERY. THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATLY 24 HOURS AFTER IMPLANTING THE DEVICE, IT CAME LOOSE FROM ONE SIDE OF THE SEPTUM AND WAS THEN REMOVED VIA SURGERY. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2649217 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 37ASD09 2512370924 04260182521564

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R