BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 23232511 · Received October 7, 2025

    Report

    Report Number
    3014616394-2025-00023
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    August 29, 2025
    Report Date
    November 11, 2025
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    PMA / PMN Number
    P200032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED BY THE CUSTOMER FOR EVALUATION. THE VISUAL AND FUNCTIONAL INVESTIGATION DID NOT CONFIRM THE SHAPE DEVELOPMENT FAILURE. THEREFORE, THE ROOT CAUSE FOR THE REPORTED FAILURE IN SHAPE DEVELOPMENT REMAINS UNKNOWN.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OCCLUDER WAS DEFORMED UPON DEPLOYMENT DURING THE INITIAL CHECK. THE DEVICE HAD NOT YET COME INTO CONTACT WITH THE PATIENT. IT WAS REPLACED WITH ANOTHER DEVICE OF THE SAME SIZE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1650632 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD30 2435293019

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown