BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 22291196 · Received June 19, 2025

    Report

    Report Number
    3014616394-2025-00007
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Date of Event
    May 19, 2025
    Report Date
    June 19, 2025
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182520741
    PMA / PMN Number
    P200032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINED DEVICE RETURNED TO OCCLUTECH FOR INVESTIGATION: THE REPORTED FLEX II ASD DEVICE SUCCESSFULLY PASSED THE 100% FUNCTIONAL INSPECTION IN ACCORDANCE WITH THE BATCH RECORD. AT THE TIME OF MARKET RELEASE, THE DEVICE MET ALL DEFINED SPECIFICATIONS. DUE TO THE CONDITION OF THE RETURNED PRODUCT (HEAVILY CONTAMINATED), IT IS NOT POSSIBLE TO DETERMINE WHETHER THE ISSUE ORIGINATED FROM IMPROPER PATCH SEWING OR EXTERNAL CONTAMINATION. THE PHYSICIAN CONFIRMED THAT THE DEVICE WAS INSPECTED PRIOR TO USE AND FOUND TO BE IN ACCEPTABLE CONDITION, WITH NO OBSERVABLE DEVIATIONS FROM THE MANUFACTURER'S SPECIFICATIONS. DURING THE PROCEDURE, HOWEVER, IRREGULAR DEPLOYMENT BEHAVIOR WAS NOTED, WHICH WAS ATTRIBUTED TO THE PATIENT'S EXTENSIVELY DEFICIENT SEPTAL RIMS. THESE ANATOMICAL FEATURES ARE KNOWN TO COMPLICATE DEVICE POSITIONING AND DEPLOYMENT. THE ABSENCE OF PRE-IMPLANTATION ABNORMALITIES, COMBINED WITH THE PRESENCE OF ANATOMICAL DEFICIENCIES, SUPPORTS THE CONCLUSION THAT PATIENT-SPECIFIC ANATOMICAL FACTORS LIKELY PLAYED A SIGNIFICANT ROLE IN THE OBSERVED ISSUE. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE REPORTED EVENT COULD NOT BE REPRODUCED DURING INTERNAL TESTING, AND NO STRUCTURAL OR MECHANICAL DEFECT WAS IDENTIFIED IN THE DEVICE AFTER PATCH REMOVAL. THE UNCERTAINTY BETWEEN THE POTENTIAL IMPACT OF PATCH SEWING AND THE OBSERVED CONTAMINATION FURTHER LIMITS THE ABILITY TO ISOLATE A SINGLE CAUSATIVE FACTOR.

    Description of Event or Problem · 0

    WE WERE INFORMED ABOUT A FAILURE IN SHAPE DEVELOPMENT EVENT OF THE ASD OCCLUDER "THE PHYSICIAN ATTEMPTED TO PLACE THE OCCLUDER ON AN APPROXIMATELY 30 MM DEFECT, BUT THE RIM WAS EXTENSIVELY DEFICIENT, MAKING PLACEMENT DIFFICULT. AFTER DEPLOYING THE LEFT DISC AND PLACING IT, THE PHYSICIAN ATTEMPTED TO DEPLOY THE RIGHT DISC. HOWEVER, IT WAS DEFORMED INTO A COBRA-HEAD LIKE SHAPE. ALTHOUGH THE RIGHT DISC WAS RELOADED AND REDEPLOYED, THE SHAPE REMAINED THE SAME. THIS OCCLUDER WAS REPLACED WITH A NEW ONE OF THE SAME MODEL, AND PLACEMENT WAS EVENTUALLY SUCCESSFUL. ANOTHER SKILLED PHYSICIAN SUPPORTED THE PHYSICIAN WHO PERFORMED THE PROCEDURE, AND THERE WAS NO APPARENT DEFECTS RELATED TO THE PROCEDURE." PATIENT IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1495851 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD33 2324293314 04260182520741

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown