BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCCLUTECH ASD OCCLUDER PROCEDURE PACK

    MDR report key: 21826201 · Received April 11, 2025

    Report

    Report Number
    3006332832-2025-00001
    Event Type
    Injury
    Date Received
    April 11, 2025
    Date of Event
    March 27, 2025
    Report Date
    July 8, 2025
    Manufacturer
    OCCLUTECH HOLDING AG
    Product Code
    OZG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, 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). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE OR PHOTOS WERE SUBMITTED TO THE MANUFACTURER FOR EVALUATION. 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. ALL MANUFACTURING PROCESSES, MATERIAL SPECIFICATIONS, AND QUALITY CONTROL TESTS ADHERED TO THE ESTABLISHED STANDARDS, CONFIRMING THAT THE BATCH MET ALL REQUIRED INTERNAL QUALITY STANDARDS. HISTORICAL DATA VERIFICATION AND TREND ANALYSIS WERE PERFORMED. NO DEVICE-RELATED ROOT CAUSE COULD BE IDENTIFIED. 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.

    Description of Event or Problem · 0

    DURING THE IMPLANTATION OF AN ASD OCCLUDER DEVICE, THE DEVICE DISLOCATED AND EMBOLIZED, REQUIRING ADDITIONAL SURGICAL INTERVENTION TO RETRIEVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121085 OCCLUTECH ASD OCCLUDER PROCEDURE PACK TRANSCATHETER SEPTAL OCCLUDER (ATRIAL) OZG OCCLUTECH HOLDING AG OPP2302

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Male Required Intervention| O