BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 24935890 · Received April 21, 2026

    Report

    Report Number
    3014616394-2026-00019
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    March 26, 2026
    Report Date
    April 21, 2026
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182520680
    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. AS REPORTED BY THE CUSTOMER THE FAILURE IN SHAPE DEVELOPMENT OCCURRED DURING THE DEVICE PREPARATION. THE VISUAL AND FUNCTIONAL INVESTIGATION OF THE RETURNED DEVICE CONFIRMED THE SHAPE DEVELOPMENT FAILURE. A MANUFACTURING-RELATED FAILURE COULD BE IDENTIFIED AS ROOT CAUSE FOR THE REPORTED EVENT. A1 - A4 IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN ATTEMPTING TO DEPLOY THE SUBJECT OCCLUDER WITHIN THE LEFT ATRIUM, IT FAILED TO EXPAND INTO THE APPROPRIATE SHAPE. UPON RETRACTING THE DEVICE OUTSIDE THE BODY TO CHECK ITS DEPLOYMENT, IT WAS OBSERVED THAT THE LA DISC HAD DEPLOYED IN AN INVERTED SHAPE. THE USE OF THE SUBJECT DEVICE WAS DISCONTINUED. IT WAS REPLACED WITH A NEW OCCLUDER AND DELIVERY SHEATH, AND THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITHOUT FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002309 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD15 2521291518 04260182520680

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown