BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 22736440 · Received August 7, 2025

    Report

    Report Number
    3014616394-2025-00012
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    June 26, 2025
    Report Date
    August 7, 2025
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182521663
    PMA / PMN Number
    P200032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. THE VISUAL AND FUNCTIONAL INVESTIGATION DID NOT CONFIRM THE SHAPE DEVELOPMENT FAILURE OF THE DEVICE, AS REPORTED BY THE CUSTOMER. ACCORDING TO THE CUSTOMER THE DEVICE COULD BE LOADED BUT WITH RESISTANCE. THE RETRACTION FORCE MEASURED DURING THE INVESTIGATION WAS WITHIN SPECIFICATION. THEREFORE, THE ORIGIN OF THE DEFECT COULD NOT BE DETERMINED AND A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. A4 IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: THE DEFECT MEASURED 24MM FROM BALLOON SIZING SO THE SURGEON CHOSE A 27MM OCCLUTECH ASD OCCLUDER. WHEN HE TRIED TO LOAD THE DEVICE AFTER FLUSHING IT INTO THE LOADER, HE HAD A HARD TIME PULLING IT IN. HE TRIED AGAIN AND ALTHOUGH SEEM TOUGHER THAN IT SHOULD HAVE BEEN, HE WAS ABLE TO LOAD THE DEVICE INTO THE LOADER. WHEN HE DEPLOYED IT INTO THE LEFT ATRIUM, THE LEFT ATRIAL DISC WOULD NOT GO INTO THE FLAT SHAPE AND APPEARS IT WAS STRETCHED OUT INTO A MORE THICK SHAPE. HE PULLED IT INTO THE LOADER AND TRIED UNSHEATHING AGAIN INTO THE LEFT ATRIUM BUT DID THE SAME THING. SO HE REMOVED THE DEVICE AS IT WAS NOT THE RIGHT SHAPE. HE PLACED A COMPETITIVE DEVICE AT THAT POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504718 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 37ASD27 2242372728 04260182521663

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female