BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDESTAR¿ STEERABLE GUIDING SHEATH

    MDR report key: 16003918 · Received December 19, 2022

    Report

    Report Number
    1035166-2022-00125
    Event Type
    Malfunction
    Date Received
    December 19, 2022
    Date of Event
    December 7, 2022
    Report Date
    July 7, 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 IS 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

    DEVICE WAS USED IN TREATMENT. ONE 14F GUIDESTAR STEERABLE GUIDING SHEATH WAS RECEIVED 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 DRIPPED AT THE FLUSHING CONNECTION AT THE WHITE PART OF THE HANDLE. THE SHEATH WAS MANUALLY LEAK TESTED WITH THE SYRINGE CONNECTED TO THE STOPCOCK AND THE TIP OCCLUDED. THE SHEATH EXHIBITED LEAKAGE FROM UNDER THE HANDLE WHEN TESTED USING THIS METHOD. THE HANDLE WAS REMOVED AND AN ELONGATED HOLE IN THE SHEATH SHAFT WAS FOUND. TESTING WITH A BORESCOPE REVEALED THAT THE PULLWIRE/COMPOSITE TUBE ASSEMBLY BREACHED THE INSIDE DIAMETER (ID) OF THE SHEATH SHAFT. THE SHEATH SHAFT WAS CUT OPEN TO EXAMINE THE LINER. IT WAS NOTICED THAT THE COLOR OF THE LINER WAS WHITE WHICH IS AN INDICATION OF OVERSTRETCHING THE LINER DURING THE SHAFT ASSEMBLY PROCESS. IT APPEARS THE OVERSTRETCHING OF THE LINER WEAKENED THE WALL ENOUGH TO ALLOW THE PULLWIRE/COMPOSITE TUBE ASSEMBLY TO BREACH THE ID OF THE SHEATH AT THE PULLWIRE EXIT DURING USE. RETURNED DEVICE ANALYSIS REVEALED THAT THE LINER INSIDE THE SHEATH SHAFT WAS OVERSTRETCHED. THIS WEAKENED THE WALL OF THE SHEATH ENOUGH TO ALLOW THE PULLWIRE/COMPOSITE TUBE ASSEMBLY TO BREACH THE ID OF THE SHEATH THUS CAUSING THE SHEATH TO LEAK UNDER THE HANDLE. THE REASON FOR RETURN WAS CONFIRMED. RETRAINING WAS CONDUCTED WITH MANUFACTURING AND QA PERSONNEL ON THEIR APPLICABLE PROCEDURES TO PREVENT RECURRENCE OF THIS ISSUE. NO MANUFACTURING REJECTS OR ANOMALIES OF THIS TYPE WERE RECORDED IN THE DEVICE HISTORY RECORD. THE INTRODUCER SHEATH PASSED ALL IN-PROCESS AND QA FINAL INSPECTION STEPS BEFORE SHIPPING TO THE CUSTOMER, INCLUDING VISUAL, DIMENSIONAL AND MECHANICAL TESTS. PER MANUFACTURING PROCEDURE (DESTINO STEERABLE GUIDING SHEATH SHAFT ASSEMBLY): SLIDE PTFE OVER THE MANDREL AND GENTLY STRETCH THE LINER DOWN ON THE MANDREL. TWIST AND TIE BOTH ENDS OF THE PTFE LINER. TRIM OFF THE EXCESS. SHRINK THE DISTAL END OF THE PTFE LINER USING A HOT BOX SET BETWEEN 650° F - 700° F FOR REFERENCE 30 SECONDS UNTIL THE PTFE LINER IS PROPERLY SHRUNK DOWN TO THE MANDREL. INSPECT THE LINER BEFORE PASSING THE MANDREL TO THE NEXT OPERATION. NOTE: DO NOT OVER STRETCH THE PTFE LINER. AN OVERSTRETCHED LINER WILL TURN WHITE OR WILL BREAK. (THIS WILL CAUSE BROKEN LINER AFTER REFLOW PROCESS). PER QA PROCEDURE (DESTINO STEERABLE GUIDING SHEATH IN-PROCESS AND FINAL INSPECTION): SAMPLE SIZE 100% ENSURE THE LINER IS TIGHTLY STRETCHED AND THE ENDS PROPERLY TIED. WHITE DISCOLORATION IS AN INDICATION THAT THE LINER IS OVERSTRETCHED. RETURN THE OVERSTRETCHED UNIT TO THE LINER STATION FOR REPLACEMENT OF LINER. THE INSTRUCTIONS FOR USE (IFU) INFORMS THE END 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. PERSONAL AWARENESS TRAINING HAS BEEN CONDUCTED TO PREVENT THE RECURRENCE OF THIS ISSUE. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED. 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

    THE GUIDESTAR SHEATH DRIPPED AT THE FLUSHING CONNECTION AT THE WHITE PART OF THE HANDLE. THE PHYSICIAN DIDN'T WANT TO CHANGE TO ANOTHER ONE DUE TO AIR MANAGEMENT. THE PROCEDURE WAS ENDED SUCCESSFULLY. SO THERE WAS NO DAMAGE AND CONSEQUENCES CAUSED TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2216427 GUIDESTAR¿ STEERABLE GUIDING SHEATH INTRODUCER, CATHETER DYB OSCOR INC. D141103 DP-16254 00885672010911

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown