BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDESTAR¿ STEERABLE GUIDING SHEATH

    MDR report key: 17995749 · Received October 24, 2023

    Report

    Report Number
    1035166-2023-00117
    Event Type
    Injury
    Date Received
    October 24, 2023
    Date of Event
    October 19, 2023
    Report Date
    February 8, 2024
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00885672010911
    PMA / PMN Number
    K140406
    Adverse Event
    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

    THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP. A1, A2, A3A, A4, B4, B5, D9, G3, G6, H2, H3, H6 & H11. ADDITIONAL INFORMATION: B5 PATIENT INFORMATION RECEIVED. ONE 14F GUIDESTAR STEERABLE GUIDING SHEATH WAS RETURNED UNDER RGA# (B)(4) WITHOUT THE DILATOR. THERE WERE NO OTHER ACCESSORIES. TRACES OF BLOOD WERE FOUND ON AND INSIDE THE SHEATH. ACCORDING TO THE EVENT DESCRIPTION SUMMARY THE SHEATH WAS FULL OF BUBBLES AND THE HEMOSTATIC VALVE DID NOT WORK PROPERLY. UPON EVALUATION OF THE RETURNED SHEATH, IT WAS OBSERVED THAT THE HEMOSTATIC VALVE WAS TORN. 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 WAS THEN TESTED USING THE ISO 11070 FOR LIQUID LEAKAGE TEST METHOD. THE SPECIFICATION FOR VALVE LEAKAGE IS 38KPA. THE DEVICE WAS OCCLUDED AT THE DISTAL TIP AND PRESSURIZED TO APPROXIMATELY 35KPA WHEN THE HEMOSTATIC VALVE STARTED TO LEAK FROM THE TEAR. PER MANUFACTURING PROCEDURE (NON-PEELABLE SHEATH FINAL ASSEMBLY) ASSEMBLING THE CAP AND SEAL VISUALLY INSPECT SEALS 100% BEFORE USE. CAREFULLY INSPECT SEALS TO ENSURE THAT THE HELICAL CENTER CUT IS PRESENT BEFORE ASSEMBLY. DO NOT PULL, BEND OR SEPARATE SEALS DURING INSPECTION. IF THE SEAL IS NOT PROPERLY CUT, REJECT THE SEAL AND DO NOT USE FOR ASSEMBLY. NOTIFY THE APPROPRIATE MANUFACTURING SUPERVISOR BEFORE PROCEEDING. PER PROCEDURE (DESTINO STEERABLE GUIDING SHEATH IN-PROCESS AND FINAL INSPECTION): THE LEAK TEST IS PERFORMED ACCORDING TO PROCEDURES BASED ON AVAILABLE LEAK TESTER. THE LEAK TEST IS PERFORMED BY MANUFACTURING PERSONNEL 100% AND IS OBSERVED BY QUALITY ASSURANCE PERSONNEL AT AN AQL LEVEL. 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. WET THE DILATOR SHAFT WITH STERILE SALINE SOLUTION PRIOR TO INSERTION THROUGH THE HEMOSTATIC VALVE. NOTE: ANY DEVICE/COMPONENT INSERTED THROUGH THE HEMOSTATIC VALVE OF THE SHEATH SHOULD BE WET AND PLACED THROUGH THE CENTER OF THE VALVE TO PREVENT TEARING OF THE SEAL AND LEAKAGE. NOTE: ANY DEVICE/COMPONENT INSERTED THROUGH THE HEMOSTATIC VALVE OF THE SHEATH SHOULD BE WET AND PLACED THROUGH THE CENTER OF THE VALVE TO PREVENT TEARING OF THE SEAL AND LEAKAGE. RETURNED DEVICE ANALYSIS REVEALED THE SHEATH WAS WITHIN MANUFACTURING SPECIFICATIONS. THERE WAS A TEAR IN THE HEMOSTATIC VALVE THAT CAUSED THE SHEATH TO LEAK AND FAIL THE ISO LEAK TEST. THE SHEATHS ARE LEAK TESTED 100% BY MANUFACTURING AND OBSERVED BY QA AT AN AQL LEVEL IN-PROCESS, PRIOR TO SHIPPING TO THE CUSTOMER. THE POTENTIAL CAUSE OF THE TEAR/LEAK COULD BE IF THE DILATOR (OR OTHER DEVICE) WAS NOT INSERTED THROUGH THE CENTER OF THE VALVE AS PER IFU. ACCORDING TO THE DEVICE HISTORY RECORD, THE SHEATH PASSED ALL IN-PROCESS AND QA FINAL INSPECTION STEPS BEFORE SHIPPING TO THE CUSTOMER INCLUDING VISUAL, DIMENSIONAL, MECHANICAL AND LEAK TESTING. NO MANUFACTURING DEFECTS WERE FOUND. THE SAMPLES ARE DISPOSITIONED PER THE APPLICABLE CUSTOMER AGREEMENT AS PER PROCEDURE (B)(4). IN CONCLUSION, BASED ON THE INFORMATION AVAILABLE AT THIS TIME IT CANNOT BE CONFIRMED THAT THE PRODUCT FAILED TO MEET REQUIREMENTS. 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

    THE CUSTOMER REPORTED THE GUIDESTAR WAS FULL OF BUBBLES; THE HEMOSTATIC VALVE DID NOT WORK PROPERLY. THE PATIENT EXPERIENCED BUBBLES IN RIGHT CORONARY. ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY; THEREFORE, A HEMODYNAMIC PROCEDURE WAS NECESSARY TO REMOVE BUBBLES. THIS RESULTED IN A PROCEDURE DELAY OF 45 MINUTES. THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE PATIENT A 72-YEAR-OLD MALE UNDERWENT AN AFIB PROCEDURE. THERE WERE NO CONSEQUENCES TO THE PATIENT, NO BLOOD LOSS REPORTED. TWO DEVICES WERE USED (OCTARAY AND HELIOSTAR BALLOON) DURING THE PROCEDURE. DE-EMBOLIZATION WAS PERFORMED DURING THE HEMODYNAMIC PROCEDURE. THE CUSTOMER STATED THE DEVICE WAS NOT SAFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237075 GUIDESTAR¿ STEERABLE GUIDING SHEATH INTRODUCER, CATHETER DYB OSCOR INC. D141103 DP-16519 00885672010911

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention| H| L