BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 22882596 · Received August 25, 2025

    Report

    Report Number
    3014616394-2025-00016
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    July 23, 2025
    Report Date
    August 25, 2025
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182520710
    PMA / PMN Number
    P200032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    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 FINAL INSPECTION OF THE REPORTED DEVICE AND ITS PROCEDURE PACK REVEALED NO DEVIATIONS AND THE ENVIRONMENTAL CONDITIONS DURING STORAGE WERE WITHIN THE LIMITS. THE VISUAL AND FUNCTIONAL INVESTIGATION CONFIRMED A SHAPE DEVELOPMENT FAILURE OF THE DEVICE, AS REPORTED BY THE CUSTOMER. ACCORDING TO THE CUSTOMER THE DEVICE FORMED INTO COBRA-SHAPE INSIDE THE PATIENT. DURING THE INITIAL QUALITY CONTROL AT THE TIME OF MANUFACTURING AND RELEASE, THE DISC DIAMETER OF THE OCCLUDER DEVICE WAS WITHIN THE SPECIFIED LIMITS. HOWEVER, AFTER IMPLANTATION, A POST-USE INSPECTION REVEALED THAT THE DISC DIAMETER WAS NO LONGER WITHIN SPECIFICATION. THIS SUGGESTS THAT THE DEVICE WAS DEFORMED DURING THE IMPLANTATION PROCESS, LIKELY DUE TO PATIENT-SPECIFIC ANATOMICAL FACTORS SUCH AS TIGHT SEPTAL TISSUE, UNUSUAL DEFECT GEOMETRY, OR EXCESSIVE MANIPULATION DURING DEPLOYMENT. SUCH MESH DEFORMATION CAN LEAD TO A "COBRA SHAPE" FAILURE, ALTHOUGH THIS REMAINS SPECULATIVE. PATIENT DATA A1 - A4 IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE OCCLUDER WAS DEPLOYED TO THE ASD, ITS DISC DEFORMED INTO A COBRA-HEAD SHAPE. CONSEQUENTLY, THE OCCLUDER WAS RETRIEVED. IT WAS REPLACED WITH A NEW ONE OF THE SAME MODEL. THE NEW OCCLUDER WAS DEPLOYED IN A GOOD SHAPE AND PLACED WITHOUT ISSUES. AN ODSIII WAS USED AS A SHEATH. WHEN A DEPLOYMENT TEST WAS PERFORMED OUTSIDE THE PATIENT'S BODY PRIOR TO ITS USE, NO ABNORMALITIES WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2823514 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD24 2411292402 04260182520710

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown