BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 20164174 · Received September 6, 2024

    Report

    Report Number
    3014616394-2024-00012
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    July 26, 2024
    Report Date
    October 25, 2024
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182520635
    PMA / PMN Number
    P200032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION: AN EVENT OF A DEVICE EMBOLISM WAS REPORTED. THE OCCLUDER WAS RECEIVED FOR ANALYSIS AND PASSED THE VISUAL INSPECTION AND ALL FUNCTIONAL TESTING. THE DIMENSIONS OF THE OCCLUDER WERE CHECKED AND CONFIRMED TO BE WITHIN SPECIFICATION. CONTAMINATION WAS NOTED. A DEVICE HISTORY REVIEW (DHR) REVEALED NO DEVIATIONS. THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL TESTS AND MET ALL SPECIFICATIONS AT THE TIME OF PRODUCTION. NO DEVIATIONS WERE FOUND IN THE INSPECTION PROTOCOL. PACKAGING AND SHIPPING WERE ACCORDING TO PROCESS. THE ENVIRONMENTAL CONDITIONS WERE WITHIN LIMITS DURING STORAGE. PER THE REPORTED INFORMATION THE DEFECT WAS INITIALLY IDENTIFIED AS AN ATRIAL SEPTAL DEFECT (ASD) VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) BUT LATER DISCOVERED TO BE A PATENT FORAMEN OVALE (PFO) DEFECT DURING THE PROCEDURE. PER THE INSTRUCTIONS FOR USE (IFU) A SECOND METHOD SUCH AS BALLOON SIZING IS RECOMMENDED TO VERIFY THE SIZE OF THE DEFECT. UTILIZATION OF A SIZING BALLOON MAY HAVE PROPERLY IDENTIFIED THE DEFECT AS A PFO PRIOR TO THE PROCEDURE. PER THE PHYSICIAN A BALLOON WAS NOT AVAILABLE FOR BALLOON SIZING. A STANDARD ASD OCCLUDER IS NOT RECOMMENDED FOR USE FOR A PFO DEFECT. BASED ON THE INVESTIGATION FINDINGS A DEVICE-RELATED FAILURE COULD NOT BE DETERMINED. THE ROOT CAUSE OF THE EVENT WAS MOST LIKELY DUE TO THE ATTEMPTED USE OF AN ASD DEVICE FOR A DEFECT THAT WAS LATER DISCOVERED TO BE A PFO.

    Additional Manufacturer Narrative · 0

    CONCLUSION: AN EVENT OF A DEVICE EMBOLISM WAS REPORTED. THE OCCLUDER WAS RECEIVED FOR ANALYSIS AND PASSED THE VISUAL INSPECTION AND ALL FUNCTIONAL TESTING. THE DIMENSIONS OF THE OCCLUDER WERE CHECKED AND CONFIRMED TO BE WITHIN SPECIFICATION. CONTAMINATION WAS NOTED. A DEVICE HISTORY REVIEW (DHR) REVEALED NO DEVIATIONS. THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL TESTS AND MET ALL SPECIFICATIONS AT THE TIME OF PRODUCTION. NO DEVIATIONS WERE FOUND IN THE INSPECTION PROTOCOL. PACKAGING AND SHIPPING WERE ACCORDING TO PROCESS. THE ENVIRONMENTAL CONDITIONS WERE WITHIN LIMITS DURING STORAGE. PER THE REPORTED INFORMATION THE DEFECT WAS INITIALLY IDENTIFIED AS AN ATRIAL SEPTAL DEFECT (ASD) VIA TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) BUT LATER DISCOVERED TO BE A PATENT FORAMEN OVALE (PFO) DEFECT. REVIEW OF THE INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT THE DEFECT MAY HAVE BEEN A MULTI-FENESTRATED ASD. A STANDARD ASD OCCLUDER WOULD NOT BE COMMENDED FOR USE FOR EITHER A MULTI-FENESTRATED ASD OR A PFO DEFECT. BASED ON THE INVESTIGATION FINDINGS A DEVICE-RELATED FAILURE COULD NOT BE DETERMINED. THE ROOT CAUSE OF THE EVENT WAS MOST LIKELY DUE TO THE ATTEMPTED USE OF AN ASD DEVICE FOR A DEFECT THAT WAS LATER DISCOVERED TO BE A PFO.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE ATTEMPTED IMPLANT OF THIS 6 MILLIMETER (MM) ATRIAL SEPTAL DEFECT (ASD) OCCLUDER THE DEFECT WAS MEASURED TO 2.9 MM VIA ECHOCARDIOGRAM (ECHO). A SIZING BALLOON WAS NOT AVAILABLE FOR BALLOON SIZING. AFTER THE DEVICE WAS POSITIONED THE PHYSICIAN NOTICED A TUNNEL. THE PHYSICIAN RECHECKED AND CONFIRMED THAT THE DEFECT WAS ADEQUATELY CLOSED. THE DEVICE WAS RELEASED AND FELL OFF THE DEFECT AFTER THREE MINUTES. THE OCCLUDER WAS REMOVED WITH A SNARE. IT WAS DETERMINED THAT THE DEFECT WAS ACTUALLY A PATENT FORAMEN OVALE (PFO) DEFECT. AN APPROPRIATELY SIZED PFO OCCLUDER WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302599 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD06 04260182520635

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male Required Intervention| L