BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 22456747 · Received July 9, 2025

    Report

    Report Number
    3014616394-2025-00008
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    March 6, 2025
    Report Date
    July 9, 2025
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182520710
    PMA / PMN Number
    P200032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL INFORMATION RECEIVED ON THIS EVENT STATED THAT THE AFFECTED DEVICE WAS A PFO OCCLUDER. ADDITIONAL INFORMATION WAS RECEIVED ON 2025-06-17 STATING THE DEVICE WAS AN ASD OCCLUDER. THE REVIEW OF THE BATCH RECORD AND INSPECTION PROTOCOLS REVEALED NO DEVIATIONS. ALL QC CRITERIA WERE WITHIN SPECIFICATION ACCORDING TO THE BATCH RECORD. THE DEVICE WAS NOT RETURNED FOR FURTHER INVESTIGATION. ACCORDING TO THE CUSTOMER THE OCCLUDER DID NOT DEVELOP THE INTENDED SHAPE DURING DEVICE PREPARATION. AS THE DEVICE WAS NOT RETURNED, NO INVESTIGATION COULD BE PERFORMED. BASED ON THE AVAILABLE INFORMATION THE FINAL ROOT CAUSE FOR THE FAILURE IN SHAPE DEVELOPMENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    DURING THE PREPARATION PROCESS FOR THE OCCLUDER, THE DEVICE DID NOT COLLAPSE ON MULTIPLE ATTEMPTS. COULD NOT GET THE DEVICE TO TAKE THE NECESSARY SHAPE TO FIT INSIDE THE LOADER/DELIVERY SYSTEM. NO CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702621 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD24 2327292403 04260182520710

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown