BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADELANTE MAGNUM

    MDR report key: 13440634 · Received February 3, 2022

    Report

    Report Number
    1035166-2022-00024
    Event Type
    Malfunction
    Date Received
    February 3, 2022
    Date of Event
    January 14, 2022
    Report Date
    July 15, 2022
    Manufacturer
    OSCOR INC
    Product Code
    DYB
    UDI-DI
    00885672004743
    PMA / PMN Number
    K140917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OUR INVESTIGATION IS STILL IN PROGRESS, FOLLOW UP REPORT WILL BE SUBMITTED IF WE FIND ANY FURTHER ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS USED FOR TREATMENT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THEREFORE, THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED. THE EXACT CAUSE OF THE PRODUCT ISSUE CANNOT BE DETERMINED. THE INVESTIGATION WAS FOCUSED ON A REVIEW OF PRODUCT DOCUMENTATION. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. HOWEVER, THE FOLLOWING CONTROLS ARE IN PLACE TO MITIGATE THE REPORTED PRODUCT ISSUE. PER ADELANTE MAGNUM INTRODUCER SHEATH IN-PROCESS AND FINAL INSPECTIONS / ADELANTE® MAGNUM. PERFORM PRESSURE AND VACUUM LEAK TEST PER PROCEDURE 4 LATEST REVISION. SAMPLING PLAN ANSI Z 1.4, GEN LEVEL I, NORMAL, AQL 0.15. PER IFU: REMOVE THE DILATOR, CATHETER, OR OTHER DEVICE SLOWLY FROM THE SHEATH. RAPID REMOVAL MAY DAMAGE THE VALVE RESULTING IN BLOOD FLOW THROUGH THE VALVE. INSERT THE DILATOR THROUGH THE CENTER OF THE SHEATH HEMOSTATIC VALVE TO PREVENT TEARING OF THE SEAL AND LEAKAGE. NO FURTHER FOLLOW-UP IS REQUIRED. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED AS FINDINGS DID NOT IDENTIFY A DESIGN, LABELING OR MANUFACTURING NON-CONFORMITY. 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 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 THAT THERE WAS BLOOD LOSS THROUGH THE THERMOSTATIC VALVE. PROCEDURE COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415344 ADELANTE MAGNUM INTRODUCER, CATHETER DYB OSCOR INC ASM018030 DP-14088 00885672004743

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown