BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCCLUTECH DELIVERY SET III

    MDR report key: 23110374 · Received September 22, 2025

    Report

    Report Number
    1035166-2025-00049
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    August 27, 2025
    Report Date
    November 5, 2025
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    PMA / PMN Number
    K210627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP 1. B4, G3, G6, H2, H6 & H11 H2: ADDED INVESTIGATION USING THE VIDEO PROVIDED BY THE CUSTOMER. H6: REMOVING LEAKING AS A REPORTABLE CODE. UPDATED CONCLUSION OUTCOME TO REFLECT COMPLAINT IS COMFIRMED. NO PRODUCT WAS RETURNED TO INTEGER FOR EVALUATION AS IT WAS DISCARDED BY THE CUSTOMER; HOWEVER, A COMPLAINT NOTIFICATION WAS PROVIDED. WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION FOR EVALUATION, INTEGER IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. DURING THE IMPLANTATION PROCEDURE, THE HEMOSTATIC VALVE DETACHED FROM THE END OF THE SHEATH WHILE ATTEMPTING TO ADVANCE THE PDA DEVICE. BASED ON THE VIDEO PROVIDED IT APPEARS THE LOADER HUB/SIDEPORT/SHAFT ARE DISENGAGING FROM THE UV GLUED ON HUB THAT ATTACHED TO THE BREEZEWAY II HUB. BASED ON THE PROVIDED VIDEO, OUR INVESTIGATION CONFIRMED THIS COMPLAINT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PATIENT HARM WAS REPORTED. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. CAPA-06152 HAS BEEN INITIATED TO ADDRESS THE BROKEN ISSUE. 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.

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED TO INTEGER FOR EVALUATION AS IT WAS DISCARDED BY THE CUSTOMER; HOWEVER, A COMPLAINT NOTIFICATION WAS PROVIDED. WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION FOR EVALUATION, INTEGER IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. DURING THE IMPLANTATION PROCEDURE, THE HEMOSTATIC VALVE DETACHED FROM THE END OF THE SHEATH WHILE ATTEMPTING TO ADVANCE THE PDA DEVICE. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. THE COMPLAINT IS NON-VERIFIABLE AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED. IN ADDITION, THERE WAS NO NEW FAILURE MODE IDENTIFIED, AND THE RISK REMAINS ACCEPTABLE. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. INTEGER WILL CONTINUE TO MONITOR THIS EVENT TYPE AND RISK. OSCOR INC. 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 OSCOR INC. 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, OSCOR INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    DURING THE IMPLANTATION PROCEDURE, THE HEMOSTATIC VALVE DETACHED FROM THE END OF THE SHEATH WHILE ATTEMPTING TO ADVANCE THE PDA DEVICE. DESPITE THIS ISSUE, THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PATIENT HARM WAS REPORTED. SUPPORTING EVIDENCE: CUSTOMER REQUEST: REPLACEMENT OF ALL SHEATHS ASSOCIATED WITH THE AFFECTED LOT NUMBER REQUESTED. DEVICE INSPECTION: NO DEVIATION NOTED DURING PRE-USE INSPECTION. DEVICE DISPOSITION: DISCARDED POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1959762 OCCLUTECH DELIVERY SET III INTRODUCER, CATHETER DYB OSCOR INC. 98US006 DP-21552

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown