BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCCLUTECH ASD OCCLUDER PROCEDURE PACK

    MDR report key: 23356386 · Received October 22, 2025

    Report

    Report Number
    3006332832-2025-00006
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    September 30, 2025
    Report Date
    December 10, 2025
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    07340175602016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, 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). ONE (1) VIDEO WAS PROVIDED TO THE INVESTIGATION TEAM. THROUGH VISUAL EXAMINATION OF THE VIDEO, NO DEVIATION OR DEVICE RELATED ROOT CAUSE COULD BE IDENTIFIED. A REVIEW OF THE BATCH RECORD WAS PERFORMED FOR THE REPORTED LOT NUMBERS 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

    ACCORDING TO THE COMPLAINANT, AN ATRIAL SEPTAL DEFECT (ASD) OCCLUDER WAS LOADED INTO THE LOADER AND PUSHER, AND SUBSEQUENTLY ADVANCED TO THE IMPLANTATION SITE DURING AN ASD CLOSURE PROCEDURE. PER THE REPORT, THE DEVICE DEPLOYED AS EXPECTED; HOWEVER, AFTER RELEASE, IT BECAME DISLODGED FROM THE INTENDED IMPLANT POSITION AND EMBOLIZED. THE DEVICE WAS RETRIEVED FROM THE PATIENT IN THE SAME PROCEDURE. A SECOND OCCLUDER DEVICE WAS SUCCESSFULLY IMPLANTED WITHOUT INCIDENT, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY AND NO ADDITIONAL ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504348 OCCLUTECH ASD OCCLUDER PROCEDURE PACK TRANSCATHETER SEPTAL OCCLUDER (ATRIAL) OZG OCCLUTECH GMBH OPP23037 07340175602016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention