BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 23232879 · Received October 7, 2025

    Report

    Report Number
    3014616394-2025-00025
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    September 11, 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
    GM
    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, A DEFINITVE ROOT CAUSE COULD NOT BE ESTABLISHED.

    Additional Manufacturer Narrative · 0

    A2 AND 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 CHANGED SHAPE DURING DEPLOYMENT IN THE PATIENT. MULTIPLE ATTEMPTS WERE MADE TO POSITION AND REDEPLOY, BUT EACH TIME IT DID NOT ACHIEVE THE CORRECT SHAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2716519 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD24 2309292403

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male