BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 22662801 · Received July 30, 2025

    Report

    Report Number
    3014616394-2025-00011
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    June 27, 2025
    Report Date
    July 29, 2025
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182521670
    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. A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE VISUAL AND FUNCTIONAL INVESTIGATION CONFIRMED THE SHAPE DEVELOPMENT FAILURE OF THE DEVICE, AS REPORTED BY THE CUSTOMER. THE INVESTIGATION CONFIRMED THAT THERE WAS A RESISTANCE DURING LOADING OF THE DEVICE BUT THE MEASURED RETRACTION FORCE WAS STILL WITHIN QC SPECIFICATIONS. ACCORDING TO THE CUSTOMER, THE DEVICE WAS TESTED PRIOR PATIENT CONTACT WITHOUT ANY DEVIATION AND THE FAILURE IN SHAPE OCCURRED DURING THE PLACEMENT OF THE OCCLUDER. THEREFORE, IT CAN BE ASSUMED THAT THE PATIENT ANATOMY CONTRIBUTED TO THE OBSERVED SHAPE DEVELOPMENT ISSUE. A2 AND A4 ARE UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS LOADED INTO LOADER AND PUSHER WITH SOME RESISTANCE, DEVICE DID NOT DEPLOY CORRECTLY IN PATIENT, DEVICE WITHDRAWN AND REMOVED FROM PATIENT. THE OCCLUDER WAS COMPLETELY DEFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513767 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 37ASD30 2243373015 04260182521670

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female