BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 23552197 · Received November 14, 2025

    Report

    Report Number
    3014616394-2025-00032
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Date of Event
    October 14, 2025
    Report Date
    November 14, 2025
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182520734
    PMA / PMN Number
    P200032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    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: INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE REVIEW OF BATCH RECORDS REVEALED NO DEVIATION. INVESTIGATION OF RETURNED DEVICE: FUNCTIONAL TESTING CONFIRMED THE SHAPE DEVELOPMENT FAILURE DURING DEVICE DEPLOYMENT. THE DIMENSIONS OF THE RETURNED DEVICE WERE WITHIN SPECIFICATION. A STRONG DEFORMATION WAS IDENTIFIED. WITH THIS DEFORMATION THE REQUIRED VISUAL INSPECTION BY THE CUSTOMER BEFORE THE PROCEDURE WOULD NOT HAVE BEEN PASSED. THE BALL DIMENSIONS OF THE DEVICE WERE WITHIN SPECIFICATION. THE COMPLAINT DEVICE (29ASD30) WAS TESTED WITH THE PUSHER USED DURING THE IMPLANTATION WITHOUT ANY COMPLICATIONS. THE DEVICE REMAINED SECURELY ATTACHED TO THE PUSHER THROUGHOUT THE ENTIRE TEST PROCEDURE. BASED ON THE AVAILABLE INFORMATION THE SHAPE DEVELOPMENT FAILURE CAN BE CAUSED BACK TO THE DEVICE DISFIGURATION/DEFORMATION. THIS DISFIGURATION MOST LIKELY HAPPENED TO STRONG FORCES BEING APPLIED TO THE DEVICE AFTER THE INSPECTION PERFORMED BY THE USER PRIOR TO THE IMPLANTATION. WHAT EXACTLY CAUSED THIS REMAINS UNKNOWN. FORCES APPLIED DURING LOADING AND DEPLOYMENT, AS WELL AS THE PATIENT'S ANATOMY, MAY ALSO INFLUENCE HOW THE OCCLUDER UNFOLDS.

    Description of Event or Problem · 0

    DURING THE PROCEDURE, AN ASD30 DEVICE WAS DELIVERED IN A FEMALE PATIENT. HOWEVER, THE DEVICE COULD NOT BE PROPERLY DEPLOYED, AS THERE WAS FAILURE IN SHAPE DEVELOPMENT. THE DEVICE WAS THEREFORE RETRACTED INTO THE SHEATH. AS THE RA DISK ENTERED THE DELIVERY SYSTEM, THE PUSHER MALFUNCTIONED AND DETACHED FROM THE DEVICE. FORTUNATELY, SINCE THE DEVICE WAS PARTIALLY WITHIN THE DELIVERY SET AT THAT POINT, THE OPERATOR WAS ABLE TO RE-ENGAGE THE PUSHER SUFFICIENTLY TO RETRIEVE THE DEVICE SAFELY. THE DEVICE WAS WITHDRAWN FROM THE BODY WITHOUT EMBOLIZATION INTO THE LA. A REPLACEMENT DEVICE AND PUSHER WERE THEN PROVIDED AND SUCCESSFULLY IMPLANTED WITHOUT FURTHER COMPLICATION. THE PATIENT TOLERATED THE PROCEDURE WELL AND EXPERIENCED NO ADVERSE OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2248488 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD30 2427293003 04260182520734

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female