BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCCLUTECH DELIVERY SET III

    MDR report key: 23594041 · Received November 19, 2025

    Report

    Report Number
    1035166-2025-00056
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    November 6, 2025
    Report Date
    May 26, 2026
    Manufacturer
    INTEGER
    Product Code
    DYB
    UDI-DI
    00885672010331
    PMA / PMN Number
    K210627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETE. INTEGER IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY INTEGER WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, INTEGER, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, INTEGER, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTEGER, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    WE WOULD LIKE TO INFORM YOU OF AN INCIDENT THAT OCCURRED ON 6 NOVEMBER 2025 DURING AN ASD CLOSURE PROCEDURE (ATRIAL SEPTAL DEFECT) AT QUEEN SIRIKIT HEART CENTER OF THE NORTHEAST, THAILAND, IN WHICH AN OCCLUTECH DELIVERY SET III (11F) WAS USED. DURING PATIENT CONTACT (DURING IMPLANTATION PROCESS) THE OCCLUTECH DELIVERY SET III (11F) IT WAS OBSERVED THAT THE SHEATH AND HUB BROKE APART INTO TWO SEPARATE PIECES. AS A RESULT, THE TEAM HAD TO REPLACE THE DEVICE WITH A NEW DELIVERY SET BEFORE PROCEEDING WITH THE NEXT STEP OF THE TREATMENT. FORTUNATELY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE SET. HOWEVER, THE INCIDENT CAUSED A DELAY OF APPROXIMATELY 20 MINUTES IN THE OVERALL PROCEDURE TIME. THE DEVICE WILL BE RETURNED; IT IS CONTAMINATED WITH BLOOD UPON OPENING. NO KNOWN INFECTIOUS DISEASE OF THE PATIENT. REASON FOR COMPLAINT DELIVERY SET FAILURE. NO DEVICE INJURY WAS INVOLVED IN ANY PATIENT, USER, OR THIRD-PARTY. THERE WERE NO OTHER PATIENT OR PROCEDURE RELATED IMPACTS, EVENTS, OR CONSEQUENCES. CONSEQUENCES TO EVENT, CLINICALLY SIGNIFICANT EXTENDED TREATMENT, OR PROCEDURE TIME. CURRENT PATIENT CONDITION IS RESOLVED. PROCEDURE COMPLETED SUCCESSFULLY WITH ANOTHER ODS III 98DS011, LOT S9699043. NO PRE-EXISTING CONDITION AND/OR PRE-DIAGNOSIS RELEVANT TO THE EVENT. PATIENT INFORMATION WAS PROVIDED. VIDEO AND PICTURE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335851 OCCLUTECH DELIVERY SET III INTRODUCER, CATHETER DYB INTEGER 98DS011 S9699043 00885672010331

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Other