BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCCLUTECH ASD OCCLUDER

    MDR report key: 23383745 · Received October 24, 2025

    Report

    Report Number
    3006332832-2025-00005
    Event Type
    Injury
    Date Received
    October 24, 2025
    Date of Event
    October 2, 2025
    Report Date
    February 13, 2026
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182521564
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). A REVIEW OF THE BATCH RECORD WAS PERFORMED FOR THE REPORTED LOT NUMBER, AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. NO SAMPLE WAS PROVIDED FOR EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: WHEN DID THE EVENT OCCUR: DURING THE FOLLOW-UP PERIOD. PIR EVENT DESCRIPTION: APPROXIMATELY 24HOURS AFTER IMPLANTING THE DEVICE, IT CAME LOOSE ON ONE SIDE OF THE SEPTUM, BUT STAYED IN PLACE, AND IT WAS DECIDED BECAUSE OF OTHER MEDICAL REASONS TO SURGICALLY REMOVE IT FROM THE PATIENT. SUMMARY OF PIR EVENT [PLEASE SELECT APPLICABLE]: OTHER, PLEASE SPECIFY: OTHER MEDICAL ISSUES OF THE PATIENT RELATING TO HIGH PRESSURES IN THE HEART. THERE IS NOT A LOCATION ON THE FORM TO INDICATE THAT THE HOSPITAL IS NOT COMPLAINING AND HAS NO KNOWLEDGE OF THIS REPORT AND IS NOT REQUESTING ANY SORT OF FOLLOW UP. THERE WAS NO HARM CAUSED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1577005 OCCLUTECH ASD OCCLUDER TRANSCATHETER SEPTAL OCCLUDER (ATRIAL) OZG OCCLUTECH GMBH OPP25106 04260182521564

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Female Required Intervention