BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 24935574 · Received April 21, 2026

    Report

    Report Number
    3014616394-2026-00018
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    January 30, 2026
    Report Date
    April 29, 2026
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182520758
    PMA / PMN Number
    P200032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A4 IS UNKNOWN. 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.

    Additional Manufacturer Narrative · 0

    BASED ON THE INVESTIGATION FINDINGS, A MANUFACTURING-RELATED FAILURE COULD BE IDENTIFIED AS ROOT CAUSE FOR THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CLOSURE PROCEDURE FOR A LARGE ATRIAL SEPTAL DEFECT (ASD), AN ASD36 PROSTHESIS WAS SELECTED BASED ON MEASUREMENTS TAKEN AFTER BALLOON MEASUREMENT. AT THE TIME OF DEVICE RELEASE WITHIN THE PATIENT, INADEQUATE PROSTHESIS BEHAVIOR WAS OBSERVED, CHARACTERIZED BY AN IMPROPER SHAPE (CUP-LIKE), PREVENTING ITS CORRECT POSITIONING AND ADAPTATION TO THE INTERATRIAL SEPTUM. DUE TO THIS ISSUE, THE PROSTHESIS WAS REMOVED FROM THE PATIENT, AND A VIDEO CALL WAS MADE BETWEEN THE MEDICAL TEAM AND A PRODUCT SPECIALIST, TO OBTAIN IMMEDIATE TECHNICAL GUIDANCE. ALL INSTRUCTIONS PROVIDED BY THE SPECIALIST WERE RIGOROUSLY FOLLOWED. HOWEVER, EVEN AFTER THE FULL APPLICATION OF THE RECOMMENDATIONS, THE PROSTHESIS CONTINUED TO PRESENT THE SAME PROBLEM, MAKING IT IMPOSSIBLE TO ACHIEVE PROPER POSITIONING AND SHAPE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404459 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD36P 2505293612 04260182520758

    Patients

    Seq Age Sex Outcome Treatment
    1