BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCCLUTECH DELIVERY SET III

    MDR report key: 21621822 · Received March 17, 2025

    Report

    Report Number
    1035166-2025-00010
    Event Type
    Injury
    Date Received
    March 17, 2025
    Date of Event
    March 5, 2025
    Report Date
    April 11, 2025
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00885672010300
    PMA / PMN Number
    K210627
    Adverse Event
    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. 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP 1. B4, G3, G6, H2, H6 & H11. NO PRODUCT WAS PROVIDED FOR ANALYSIS AS PRODUCT WAS DISCARDED BY CUSTOMER. THE CUSTOMER STATED THE SHEATH WAS FLUSHED THEN ASPIRATED WITH 20ML OF BLOOD TO REMOVE AIR FROM THE SHEATH. ECG HAS CHANGED AND THE PATIENT FELT CHEST PAIN AND SHORTNESS OF BREATH. AIR EMBOLIE WAS SUSPECTED. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. NO PRODUCT WAS RETURNED TO OSCOR INC. FOR EVALUATION; HOWEVER, A COMPLAINT NOTIFICATION WAS PROVIDED. WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION FOR EVALUATION, OSCOR INC. IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. THE COMPLAINT IS NON-VERIFIABLE AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. IFU: POTENTIAL ADVERSE EFFECTS INCLUDE AIR EMBOLISM. 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. OSCOR 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 HAVE NOT 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

    PRIOR TO IMPLANTATION OCCLUDER WAS FLUSHED, LOADED 2X AND ALWAYS FLUSHED WITH WATER TO REMOVE AIR BUBBLES FROM THE DEVICE AND MATERIAL. SHEATH WAS FLUSHED AS WELL AND ONCE PLACED IN THE PATIENT WE ASPIRATED 20ML OF BLOOD TO REMOVE AIR FROM THE SHEATH AFTER DILATOR REMOVAL. THEN LOADER TOGETHER WITH THE OCCLUDER WAS UNDER CONSTANT FLUSH CONNECTED TO THE DELIVERY SHEATH. AFTER THE LEFT SIDE OF THE OCCLUDER WAS DEPLOYED ECG HAS CHANGED AND THE PATIENT FELT CHEST PAIN AND SHORTNESS OF BREATH. AIR EMBOLIE WAS SUSPECTED. AFTER 5-7 MIN ECG WAS AGAIN NORMAL AND THE CHEST PAIN WAS LESS PRESENT IN THE PATIENT. THE DEVICE WAS IMPLANTED, AND THE PATIENT WAS DISCHARGED WITHOUT ANY CONSEQUENCES. DEVICE WAS DISCARDED BY HOSPITAL. CONSEQUENCES TO EVENT: AIR ENTERING INTO VASCULAR SYSTEM & EMBOLISM. (B)(6)2025: CUSTOMER PROVIDED ADDITIONAL DETAILS: PROCEDURE TAKING PLACE WHEN ISSUE WAS FOUND WAS TO CLOSE THE PFO (PATENTED FORAMEN OVALE). IT IS UNKNOWN EXACTLY WHEN THE AIR GOT INTO THE DEVICE BUT IT WAS NOTICED (ECG CHANGED AND PATIENT COMPLAINED ABOUT THE CHEST PAIN AND BREATHING ISSUES) SHORTLY AFTER THE LEFT SIDE OF THE PFO DEVICE WAS DEPLOYED. THERE WAS A SHORT DELAY OF 10-15 MORE MINUTES UNTIL THE AIR WAS FLUSHED FROM THE HEART AND PATIENT STARTED FEELING BETTER. THE PATIENT RECEIVED SUBLINGUAL NITROGLYCERIN AND GOT BETTER. WE HAD TO WAIT UNTIL THE AIR WAS FLUSHED OUT OF THE HEART AND AS MENTIONED ABOVE SECOND PATIENT RECEIVED NITROGLYCERIN JUST TO EASE HER PAIN/AIR EMBOLISM. PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4738 OCCLUTECH DELIVERY SET III INTRODUCER, CATHETER DYB OSCOR INC. 98DS010 DP-21549 00885672010300

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| L