BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 22563545 · Received July 22, 2025

    Report

    Report Number
    3014616394-2025-00009
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    June 12, 2025
    Report Date
    July 22, 2025
    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

    THE DEVICE WAS RETURNED FOR INVESTIGATION. IT WAS FOUND THAT THE INHOMOGENEITY OF THE WIRE MESH WAS CAUSED BY THE INSERTION OF THE DEVICE INTO AN UNAPPROVED SHEATH. THE ACCOMPANYING UNAPPROVED SHEATH WAS SIGNIFICANTLY MORE RIGID IN TERMS OF MATERIAL PROPERTIES COMPARED TO THE RECOMMENDED SHEATH. DURING INSERTION, THE LA ATRIAL DISC SHIFTED, RESULTING IN AN INHOMOGENEOUS MESH STRUCTURE. THEREFORE, THE IDENTIFIED ROOT CAUSE WAS NOT FOLLOWING THE IFU.

    Additional Manufacturer Narrative · 0

    A1-A4 IS UNKNOWN. THE REVIEW OF THE BATCH RECORD AND INSPECTION PROTOCOLS OF THE REPORTED DEVICE REVEALED NO DEVIATION. NO OTHER COMPLAINT EXISTS FROM THE REPORTED LOT REGARDING THE SAME COMPLAINT REASON. ALL QC CRITERIA WERE WITHIN SPECIFICATION ACCORDING TO THE BATCH RECORD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN N 36 PROSTHESIS WAS PREPARED AND INSERTED INTO THE 12 F SHEATH. THE LEFT DISC WAS RELEASED AND DID NOT ASSUME A FLAT DISC-LIKE SHAPE BUT RATHER BULGED LIKE A BALLOON. IT WAS INSTRUCTED THAT THE PROSTHESIS BE REMOVED AND WE OBSERVED THAT THE CENTRAL PART OF THE RIGHT DISC WAS COMPLETELY OPEN, PREVENTING THE NORMAL CONFIGURATION OF THE DISC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802232 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD36P 2436293614 04260182520758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown