BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDESTAR¿ STEERABLE GUIDING SHEATH

    MDR report key: 15738609 · Received November 4, 2022

    Report

    Report Number
    1035166-2022-00117
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Date of Event
    October 6, 2022
    Report Date
    March 3, 2023
    Manufacturer
    OSCOR INC
    Product Code
    DYB
    UDI-DI
    00885672010911
    PMA / PMN Number
    K140406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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

    ONE 14F GUIDESTAR STEERABLE GUIDING SHEATH WAS RECEIVED WITH THE DILATOR. THERE WERE NO OTHER ACCESSORIES. TRACES OF BLOOD WERE FOUND ON AND INSIDE THE SHEATH AND DILATOR. ACCORDING TO THE EVENT DESCRIPTION SUMMARY, THE PHYSICIAN ASPIRATED AIR INTO THE SYRINGE AND FELT THAT THE HEMOSTATIC VALVE WAS DEFECTIVE. THE HEMOSTATIC VALVE WAS VIEWED UNDER A MICROSCOPE AND LOOKED NORMAL WITH NO ANOMALIES. THE SHEATH WAS MANUALLY LEAK TESTED WITH THE SYRINGE CONNECTED TO THE STOPCOCK AND THE TIP OCCLUDED. THE SHEATH DID NOT EXHIBIT LEAKAGE WHEN TESTED USING THIS METHOD. THE SHEATH ALSO ASPIRATED AS EXPECTED AND NO AIR BUBBLES WERE SEEN INSIDE THE SYRINGE. THE SHEATH WAS THEN TESTED USING THE ISO 11070 FOR LIQUID LEAKAGE TEST METHOD. THE DEVICE WAS OCCLUDED AT THE DISTAL TIP AND PRESSURIZED TO 38KPA AND HELD AT THIS PRESSURE FOR 30 SECONDS AND NO LEAKAGE WAS OBSERVED FROM THE HEMOSTATIC VALVE. THE SHEATH WAS FURTHER PRESSURIZED BEYOND 300KPA AND NO LEAKAGE WAS OBSERVED FROM THE STOPCOCK, SIDEPORT TUBING OR THROUGH THE HANDLE. RETURNED DEVICE ANALYSIS REVEALED THE SHEATH WAS WITHIN MANUFACTURING SPECIFICATIONS. THE HEMOSTATIC VALVE LOOKED NORMAL AND INTACT. THE SHEATH DID NOT LEAK WHEN TESTED MANUALLY AND ALSO ASPIRATED AS EXPECTED. THE SHEATH MET THE ISO LEAKAGE TEST METHOD REQUIREMENT. THE SHEATHS ARE LEAK TESTED 100% BY MANUFACTURING AND OBSERVED BY QA AT AN AQL LEVEL. ACCORDING TO THE DHR, THE SHEATH PASSED ALL IN-PROCESS AND FINAL INSPECTION STEPS INCLUDING VISUAL, MECHANICAL, DIMENSIONAL AND LEAK TESTING. NO MANUFACTURING DEFECTS WERE FOUND. PER 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 AT AQL LEVEL ANSI Z 1.4, GEN LEVEL I, NORMAL, AQL 1.5 NORMAL. PER IFU 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

    DURING AN AFIB PROCEDURE WITH THE HELIOSTAR BALLOON, THE GUIDESTAR SHEATH WAS INTRODUCED INTO THE LEFT ATRIUM OF THE PATIENT. THE PHYSICIAN ASPIRATED AFTER INTRODUCING IT AND RETRACTING THE DILATOR AS USUAL, BUT HE SAW A LOT OF AIR INSIDE THE SYRINGE. HE ASPIRATED AGAIN AND MORE AIR CAME OUT OF THE SHEATH. MUCH MORE THAN USUAL. SEEMS THAT THE VALVE OF THE SHEATH WAS DEFECTIVE. WE HAVE CHANGED IT TO A NEW ONE AND THE ISSUE WAS SOLVED. NO PATIENT HARM REPEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2251282 GUIDESTAR¿ STEERABLE GUIDING SHEATH INTRODUCER, CATHETER DYB OSCOR INC D141103 DP-16237 00885672010911

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown