BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 23355531 · Received October 22, 2025

    Report

    Report Number
    3014616394-2025-00027
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    September 23, 2025
    Report Date
    January 16, 2026
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182520710
    PMA / PMN Number
    P200032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATCH RECORD REVIEW, INSPECTION PROTOCOLS AND THE PACKAGING OF THE COMPLAINED FLEX II ASD (29ASD24 S/N: (B)(6) OCCLUDER REVEALED NO DEVIATIONS. THE FINAL INSPECTION OF THE REPORTED FLEX II ASD AND ITS PROCEDURE PACK REVEALED NO DEVIATIONS. THE VISUAL AND FUNCTIONAL INVESTIGATION DID NOT CONFIRM THE SHAPE DEVELOPMENT FAILURE OF FLEX II ASD OCCLUDER AS REPORTED BY THE CUSTOMER. BASED ON THE AVAILABLE INFORMATION THE FINAL ROOT CAUSE FOR THE FAILURE IN SHAPE DEVELOPMENT REMAINS UNKNOWN.SHAPE DEVELOPMENT VARIATIONS IN BRAIDED OCCLUDERS ARE GENERALLY CONSIDERED UNAVOIDABLE. FACTORS SUCH AS WIRE TENSION VARIABILITY, MATERIAL PROPERTIES, DEVICE FLEXIBILITY, AND THE DYNAMIC INTERACTIONS BETWEEN THE BRAIDED WIRES COMPLICATE THE MANUFACTURING OF OCCLUDERS WITH IDENTICAL WIRE INTERACTIONS. THESE INHERENT COMPLEXITIES MAKE IT DIFFICULT TO REPRODUCE THE REPORTED ISSUE.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE ASD OCCLUDER PROPER DEPLOYMENT AND ACHIEVEMENT OF THE CORRECT DEVICE SHAPE COULD NOT BE OBTAINED DESPITE MULTIPLE ATTEMPTS. THE DEVICE WAS SUBSEQUENTLY REMOVED WITHOUT COMPLICATION. A NEW DEVICE WAS PROVIDED AND SUCCESSFULLY IMPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE ASD OCCLUDER PROPER DEPLOYMENT AND ACHIEVEMENT OF THE CORRECT DEVICE SHAPE COULD NOT BE OBTAINED DESPITE MULTIPLE ATTEMPTS. THE DEVICE WAS SUBSEQUENTLY REMOVED WITHOUT COMPLICATION. A NEW DEVICE WAS PROVIDED AND SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241311 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD24 2424292402 04260182520710

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female