BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 22641528 · Received July 29, 2025

    Report

    Report Number
    3014616394-2025-00010
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    June 27, 2025
    Report Date
    July 29, 2025
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182521663
    PMA / PMN Number
    P200032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    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, WHICH WAS NOT IDENTIFIED IN THE QC INSPECTION, COULD BE IDENTIFIED AS ROOT CAUSE FOR THE REPORTED EVENT. A2 AND A4 IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE LOADED INTO LOADER AND PUSHER. PRIOR TO INSERTION INTO THE PATIENT, AN ATTEMPT WAS MADE TO DEPLOY THEY DEVICE OUTSIDE OF THE BODY. THE OCCLUDER WOULD NOT PROPERLY DEPLOY. DEVICE NOT PUT IN PATIENT. COMPETITOR DEVICE IMPLANTED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2577071 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 37ASD27 2242372728 04260182521663

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female