BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCCLUTECH DELIVERY SET III

    MDR report key: 16618555 · Received March 27, 2023

    Report

    Report Number
    1035166-2023-00034
    Event Type
    Malfunction
    Date Received
    March 27, 2023
    Date of Event
    January 1, 2023
    Report Date
    August 10, 2023
    Manufacturer
    OSCOR.INC
    Product Code
    DYB
    UDI-DI
    00885672010270
    PMA / PMN Number
    K210627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. A REVIEW OF THE MANUFACTURING PROCESSES INDICATES THE PRODUCTION OPERATORS ARE INSTRUCTED TO 100% VISUALLY INSPECT FOR ANY OBVIOUS DEFECT PRIOR TO SHIPMENT. 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. 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

    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.

    Description of Event or Problem · 0

    DURING TESTS OF THE NEW ODS ILL IN 3 HOSPITALS WITH A TOTAL OF 4 ODSIII THERE WAS A LEAKAGE AT THE HEMOSTATIC VALVE OF THE LOADER IN ALL 4 ODSIII, WHEN THEY WORKED WITH THE CONTRAST MEDIA PUMP (FLOW 15MUSEC; VOLUME 20ML). THEY TRIED TO HANDLE IT WITH LESS FLOW/MIN (FLOW 1 0MUMIN, VOLUME 15ML) WITH THE SAME RESULT - A CONTRAST MEDIUM JET SPRAYED OUT THROUGH THE HEMOSTATIC VALVE. AT LEAST A PART OF THE CONTRAST MEDIA ARRIVED AT THE TARGET TO VERIFY THE POSITION OF THE OCCLUDER. ALL THREE HOSPITALS DECIDED TO CONTINUE WITH THE OLDER ODS VERSION, AS THEY NEVER HAD THIS ISSUE WITH THE SCREW MECHANISM. THESE HOSPITALS PERFORM THERE PFO-CLOSURES ONLY WITH FLUOROSCOPY AND CONTRAST MEDIA AND TO HAVE A SAVE EVALUATION OF THE DEVICE POSITION, THEY ARE RELIANT TO THE CONTRAST MEDIA PUMP.THERE WAS NO HARM OF ANY PATIENT. THIS EVENT IS ADDRESSED UNDER (B)(4). SECOND EVENT IS ADDRESSED UNDER (B)(4). THIRD EVENT IS ADDRESSED UNDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691186 OCCLUTECH DELIVERY SET III INTRODUCER, CATHETER DYB OSCOR.INC 98DS009 DP-16709 00885672010270

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown