BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCCLUTECH DELIVERY SET III

    MDR report key: 23646895 · Received November 25, 2025

    Report

    Report Number
    1035166-2025-00059
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    November 5, 2025
    Report Date
    November 25, 2025
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00885672010270
    PMA / PMN Number
    K210627
    Adverse Event
    Yes
    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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS AN EVENT THAT WAS CLASSIFIED AS RESULTING IN DEATH. IT IS UNCLEAR WHETHER THIS OUTCOME IS RELATED TO THE DEVICE. EVENT WAS CLARIFIED THAT THE DEATH MENTIONED IN THE REPORT WAS SIMPLY A MISUNDERSTANDING BETWEEN THE PHYSICIAN AND THE HOSPITAL PHARMACIST WHO INITIALLY REPORTED THE COMPLAINT. THE ISSUE WAS VERBALLY COMMUNICATED AS LOADER BREAKAGE AT THE FIXATION POINT, BUT WE DON'T YET HAVE WRITTEN CONFIRMATION. AT THIS POINT, WE ONLY KNOW THAT THE OUTCOME WAS NOT A DEATH. ADDITIONAL INFORMATION: EVENT OCCURRED AT A PFO CLOSURE PROCEDURE, THE LOADER OF ODS III WAS SLIGHTLY CRACKED AT THE FIXATION POINT (ROUND CUP) TO THE SHEATH BUT WAS NOT BROKEN AND NO ONE REALIZED (PHYSICIANS AND ME) DURING INCOMING INSPECTION AND PRIOR TO PATIENT CONTACT, DURING DEVICE PREPARATION AND BEFORE DEVICE POSITIONING. DURING IMPLANTATION PROCESS, IT RESULTED THAT THE LOADER DISCONNECTED FROM THE PROXIMAL PART OF THE SHEATH AT THE LEVEL OF THE ANTI-REFLUX VALVE JUST DURING RELEASING OF DEVICE. IT RESULTED IN AN AIR BUBBLE THAT TRIGGERED A MEDICAL ALERT AND ST SEGMENT ELEVATION ON THE ELECTROCARDIOGRAM: ATROPINE WAS INJECTED FOR SINUS BRADYCARDIA (ELECTROCARDIOGRAM'S SINUS RHYTHM). THERE WAS A DEVICE INJURY INVOLVED WITH PATIENT. THERE WERE NO OTHER PATIENT OR PROCEDURE RELATED IMPACTS, EVENTS, OR CONSEQUENCES. LISTED CONSEQUENCES TO EVENT WERE CLINICALLY SIGNIFICANT EXTENDED TREATMENT OR PROCEDURE TIME, ATROPINE REQUIRED AND AIR ENTERING VASCULAR SYSTEM. PATIENT IS IN GOOD CONDITION, REQUIRED ADDITIONAL MEDICATION. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO OTHER DEVICE WAS USED TO COMPLETE PROCEDURE. PER REPRESENTATIVES' OPTION, THE PROCEDURE WAS DELAYED BY APPROXIMATELY BY 10 MINUTES AND THE PATIENT'S CURRENT CONDITION HAS BEEN REPORTED AS GOOD. DEVICE IS AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947691 OCCLUTECH DELIVERY SET III INTRODUCER, CATHETER DYB OSCOR INC. 98DS009 DP-21448 00885672010270

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H