BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCCLUTECH ASD OCCLUDER PROCEDURE PACK

    MDR report key: 23089470 · Received September 18, 2025

    Report

    Report Number
    3006332832-2025-00003
    Event Type
    Injury
    Date Received
    September 18, 2025
    Date of Event
    August 29, 2025
    Report Date
    September 30, 2025
    Manufacturer
    OCCLUTECH HOLDING AG
    Product Code
    OZG
    UDI-DI
    07340175601965
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, 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 HISTORY 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: PIR EVENT DESCRIPTION: THE ASD MEASURED ABOUT 6MM AT STATIC MEASUREMENT UNDER ICE IMAGING. NO BALLOON SIZING WAS PERFORMED. 9MM WAS IMPLANTED AND PROCEDURE WAS COMPLETE. LATER THAT DAY, ECHO/CXR SHOWED THE DEVICE WAS EMBOLIZED TO THE DESCENDING AORTA. PATIENT WAS TAKEN BACK TO THE LAB AND THE DEVICE WAS REMOVED SUCCESSFULLY AND GORE SEPTAL OCCLUDER WAS IMPLANTED UNDER ICE. BALLOON SIZING WAS USED FOR THE IMPLANTATION OF THE GORE DEVICE AND THE PATIENT WENT HOME AND IS DOING WELL. DR. (B)(6) SAID, THE OCCLUTECH DEVICE WAS UNDERSIZED AND REASON FOR EMBOLIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2840501 OCCLUTECH ASD OCCLUDER PROCEDURE PACK TRANSCATHETER SEPTAL OCCLUDER (ATRIAL) OZG OCCLUTECH HOLDING AG OPP23032 07340175601965

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male