BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCCULTECH ASD OCCLUDER

    MDR report key: 23127113 · Received September 23, 2025

    Report

    Report Number
    3006332832-2025-00004
    Event Type
    Injury
    Date Received
    September 23, 2025
    Date of Event
    September 9, 2025
    Report Date
    October 24, 2025
    Manufacturer
    OCCLUTECH HOLDING AG
    Product Code
    OZG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, 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). MULTIPLE TEE IMAGES WERE SUBMITTED TO THE MANUFACTURER FOR EVALUATION. THROUGH VISUAL EXAMINATION OF THE IMAGES, NO DEVIATIONS OR DEVICE RELATED ROOT CAUSE COULD BE IDENTIFIED. A COMPREHENSIVE REVIEW OF THE BATCH RECORD INFORMATION WAS PERFORMED. THE BATCH RECORD OF THE COMPLAINT PRODUCT WAS THOROUGHLY EXAMINED, AND NO DEVIATION WAS IDENTIFIED. ALL MANUFACTURING PROCESSES, MATERIAL SPECIFICATIONS AND QUALITY CONTROL TESTS ADHERED TO THE ESTABLISHED STANDARDS, CONFIRMING THAT THE BATCH MET ALL REQUIRED INTERNAL QUALITY STANDARDS. 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. CORRECTION: B1 & B2 HAVE BEEN CORRECTED AFTER FURTHER REVIEW OF THE COMPLAINT.

    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: - DEVICE EMBOLIZED TO THE AORTA WAS FOUND ON A PRE-DISCHARGE ECHO ROUGHLY 2 HOURS AFTER PLACEMENT. DEVICE WAS SUCCESSFULLY RETRIEVED WITH A 9F SHEATH AND SNARE. - DEFECT WAS LATER DETERMINED TO BE A LONG TUBULAR PFO AND SUCCESSFULLY CLOSED WITH A 25MM CRIBRIFORM DEVICE. - TEE MEASURED 8MM AND BALLOON SIZING MEASURED 13.5MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201425 OCCULTECH ASD OCCLUDER TRANSCATHETER SEPTAL OCCLUDER (ATRIAL) OZG OCCLUTECH HOLDING AG

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male Required Intervention