BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 23232323 · Received October 7, 2025

    Report

    Report Number
    3014616394-2025-00022
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    August 25, 2025
    Report Date
    November 18, 2025
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182520710
    PMA / PMN Number
    P200032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. DURING THE VISUAL AND FUNCTIONAL DEVICE INVESTIGATION THE REPORTED FAILURE IN SHAPE DEVELOPMENT COULD NOT BE REPRODUCE. ACCORDING TO THE INFORMATION THE DEVICE COULD NOT DEVELOP ITS INTERNET SHAPE IN THE SEPTUM WE CAN ASSUME THAT THE PATIENT'S ANATOMY COULD PLAY A CRUCIAL ROLE IN THE DEPLOYMENT. BASED ON THE AVAILABLE INFORMATION THE FINAL ROOT CAUSE FOR THE FAILURE IN SHAPE DEVELOPMENT REMAINS UNKNOWN

    Additional Manufacturer Narrative · 0

    A1-A4 IS UNKNOWN. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN DEPLOYING THE DEVICE IN THE PATIENT THE DEVICE WOULDN'T ALIGN WITH THE SEPTUM AND APPEARED A GLOBULAR SHAPE AND DIDN'T FLATTEN. IT WAS REMOVED FROM THE PATIENT WITHOUT RELEASE. ON EXAMINATION ON THE TABLE WHEN EXTENDED FROM THE LOADER THE DEVICE DIDN'T FORM UP CORRECTLY. ANOTHER OCCLUTECH DEVICE WAS USED AND THE ASD WAS SUCCESSFULLY CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN DEPLOYING THE DEVICE IN THE PATIENT THE DEVICE WOULDN'T ALIGN WITH THE SEPTUM AND APPEARED A GLOBULAR SHAPE AND DIDN'T FLATTEN. IT WAS REMOVED FROM THE PATIENT WITHOUT RELEASE. ON EXAMINATION ON THE TABLE WHEN EXTENDED FROM THE LOADER THE DEVICE DIDN'T FORM UP CORRECTLY. ANOTHER OCCLUTECH DEVICE WAS USED AND THE ASD WAS SUCCESSFULLY CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2690619 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD24 2411292414 04260182520710

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown