BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDESTAR¿ STEERABLE GUIDING SHEATH

    MDR report key: 15685407 · Received October 27, 2022

    Report

    Report Number
    1035166-2022-00114
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Date of Event
    October 14, 2022
    Report Date
    January 20, 2023
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00885672010911
    PMA / PMN Number
    K140406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP 1: B4, G3, G6, H2, H6, AND H10 THE DEVICE WAS USED IN THE TREATMENT. THE DEVICE WAS DISCARDED AND NOT RETURNED FOR ANALYSIS; THEREFORE, THE EXACT CAUSE OF THE PRODUCT ISSUE CANNOT BE DETERMINED AND THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. THE FOLLOWING CONTROLS ARE IN PLACE TO MITIGATE THE REPORTED PRODUCT ISSUE. PER MANUFACTURING PROCEDURE ADELANTE MAGNUM AND DESTINO MAGNUM SHEATH ASSEMBLY: SAMPLE SIZE 100%: THE VALVES ARE VISUALLY INSPECTED BEFORE FINAL ASSEMBLY. LEAK TEST CURED SHEATH ASSEMBLIES PER PROCEDURE. PER QA PROCEDURE DESTINO STEERABLE GUIDING SHEATH IN-PROCESS AND FINAL INSPECTION: SAMPLE SIZE: ANSI Z 1.4, GEN LEVEL I, NORMAL, AQL 1.5 NORMAL PERFORM LEAK TEST ACCORDING TO PROCEDURE BASED ON AVAILABLE LEAK TESTER. THE LEAK TEST IS PERFORMED BY MANUFACTURING PERSONNEL AT 100% AND IS OBSERVED BY QUALITY ASSURANCE PERSONNEL THE INSTRUCTIONS FOR USE (IFU) INFORMS THE USER: THE STEERABLE SHEATH MUST BE THOROUGHLY FLUSHED WITH EITHER SALINE OR HEPARINIZED SALINE AND FREE OF AIR PRIOR TO USE TO AVOID AIR EMBOLISM TO THE PATIENT. ASPIRATION AND FLUSHING OF THE SHEATH SHOULD BE PERFORMED FREQUENTLY TO HELP MINIMIZE THE POTENTIAL FOR AIR EMBOLISM. FOR INJECTING OR ASPIRATING THROUGH THE SHEATH, USE THE SIDEPORT ONLY WITH STOPCOCK. PRIOR TO INFUSION, REMOVE ALL AIR USING THE SIDEPORT. 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 THE GUIDESTAR SHEATH WAS LEAKING AND VALVE SEEMED TO NOT WORK RIGHT. UNFORTUNATELY THE GUIDESTAR WAS THROWN AWAY. PROCEDURE WAS SUCCESSFUL BY CHANGING OUT CATHETER. NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2776865 GUIDESTAR¿ STEERABLE GUIDING SHEATH INTRODUCER, CATHETER DYB OSCOR INC. D141103 DP-16237 00885672010911

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown