BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 23656940 · Received November 26, 2025

    Report

    Report Number
    3014616394-2025-00033
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    October 22, 2025
    Report Date
    December 10, 2025
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182520727
    PMA / PMN Number
    P200032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVESTIGATION DID NOT REVEAL ANY DEVIATIONS RELATED TO THE DEVICE ITSELF, HOWEVER, THE COMPLAINED THROMBUS WAS OBSERVED ON THE COMPLAINT DEVICE. "THROMBUS ON THE DEVICE" IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE CORRESPONDING IFU. THE CUSTOMERS ARE INSTRUCTED TO FOLLOW THE WARNINGS AND PREVENTIVE MEASURES WHICH ARE PRESENT IN THE IFU TO PREVENT OCCURRENCE OF SUCH EVENTS. BASED ON THE MEDICAL EXPERT OPINION (ROOT CAUSE OF THIS EVENT), THROMBUS FORMATION OCCURRED DUE TO PROCEDURE RELATED ISSUES. MULTIPLE ATTEMPTS FOR DEVICE PLACEMENT INCREASED CLOTTING RISK, WHICH WAS NOT MITIGATED BY MEDICATION OR MONITORING ACTIVATED CLOTTING TIME. CONSIDERING ALL INVESTIGATION FINDINGS, AS WELL AS THE MEDICAL EXPERT ASSESSMENT, THE ROOT CAUSE OF THE EVENT IS TRACED BACK TO NON-DEVICE-RELATED FACTORS.

    Additional Manufacturer Narrative · 0

    A4 IS UNKNOWN. THE REVIEW OF THE BATCH RECORD AND INSPECTION PROTOCOLS OF THE REPORTED DEVICE REVEALED NO DEVIATION. NO OTHER COMPLAINT EXISTS FROM THE REPORTED LOT REGARDING THE SAME COMPLAINT REASON. ALL QC CRITERIA WERE WITHIN SPECIFICATION ACCORDING TO THE BATCH RECORD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER ATTEMPTING TO DEPLOY THE OCCLUDER SEVERAL TIMES AT THE ASD, TEE SUSPECTED THROMBUS ON THE DEVICE'S LA DISC. CONSEQUENTLY, THE OCCLUDER AND SHEATH WERE RETRIEVED. THROMBUS WAS CONFIRMED ON THE LA DISC OF THE RETRIEVED DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW OCCLUDER. THERE WAS NO PATIENT INJURY. THE PATIENT'S ACT WAS REPORTED TO BE WITHIN ACCEPTABLE LIMITS DURING THE PROCEDURE AND THE PATIENT HAD NO KNOWN HEREDITARY ISSUES OR COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER ATTEMPTING TO DEPLOY THE OCCLUDER SEVERAL TIMES AT THE ASD, TEE SUSPECTED THROMBUS ON THE DEVICE'S LA DISC. CONSEQUENTLY, THE OCCLUDER AND SHEATH WERE RETRIEVED. THROMBUS WAS CONFIRMED ON THE LA DISC OF THE RETRIEVED DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW OCCLUDER. THERE WAS NO PATIENT INJURY. THE PATIENT'S ACT WAS REPORTED TO BE WITHIN ACCEPTABLE LIMITS DURING THE PROCEDURE AND THE PATIENT HAD NO KNOWN HEREDITARY ISSUES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2137022 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD27 2405292710 04260182520727

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male Life Threatening| R