BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOURGUIDE¿ STEERABLE SHEATH

    MDR report key: 16368630 · Received February 13, 2023

    Report

    Report Number
    1035166-2023-00017
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    January 18, 2023
    Report Date
    July 15, 2023
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00850232006055
    PMA / PMN Number
    K120459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO SECTION B4: 15-JUL-2023. 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

    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, D9, G3, G6, H2, H3, H6, AND H10. ONE 7F TOURGUIDE STEERABLE INTRODUCER SHEATH WAS RECEIVED BACK FROM THE CUSTOMER WITH THE DILATOR. THERE WERE NO OTHER ACCESSORIES. NO VISIBLE BLOOD WAS FOUND ON OR INSIDE THE SHEATH OR DILATOR. ACCORDING TO THE EVENT DESCRIPTION SUMMARY, THE TOURGUIDE DILATOR IS NOT CLICKING INTO THE GUIDE CATHETER HUB AT ALL. UPON EVALUATION, IT WAS FOUND THAT THE HUB CAP RIM OF THE SHEATH WHERE THE DILATOR LOCKS INTO LOOKED NORMAL WITH NO OBVIOUS SIGNS OF DAMAGE IN COMPARISON TO THE DRAWING. THE GEOMETRY OF THE HUB ON THE DILATOR LOOKED ABNORMAL IN THE AREA THAT LOCKS INTO THE SHEATH'S HUB CAP IN COMPARISON TO THE DRAWING. THE DILATOR HUB WAS NO LONGER UNIFORM IN DIAMETER AND LOOKED LIKE THE USER WAS TRYING TO FORCE THE DILATOR TO LOCK ONTO THE SHEATH CAUSING THE HUB MATERIAL TO CRUSH AND BUCKLE. RETURNED DEVICE ANALYSIS REVEALED THAT THE DILATOR WOULD NOT LOCK ONTO THE SHEATH. THE REASON FOR RETURN WAS CONFIRMED. A DIRECT ASSESSMENT OF ON HAND INVENTORY REVEALED THAT THE TRUE PHYSICAL DIMENSION PRESENT IN THE MOLDED DILATORS IS 0.147", WHICH REQUIRES EXCESSIVE FORCE TO MATE WITH THE 0.137" SNAP CAP INNER DIAMETER (ID). FURTHER INVESTIGATION ON THE DRAWINGS CORRESPONDING TO THE MOLD, INDICATED THAT THE INTENDED OUTSIDE DIAMETER FOR THE DILATOR SNAP FEATURE IS INDEED 0.147" AFTER THE SHRINKAGE FACTOR IS CONSIDERED. THE MOLD DRAWING INDICATED THAT THE DIMENSION WAS INADVERTENTLY UPDATED TO 0.147" FROM 0.142", WHICH WOULD BE INDICATIVE OF THE POINT WHERE THE REPORTED CONDITION WAS INTRODUCED. SO, MOST PROBABLY ROOT CAUSE IS SHUT OFF DIMENSIONALLY OUT OF SPECIFICATION. MANUFACTURING AND QA PERSONNEL HAVE BEEN NOTIFIED OF THIS ISSUE. CAPA WAS OPENED TO INVESTIGATE THE ROOT CAUSE AND IMPLEMENT CORRECTIVE ACTION TO PREVENT RECURRENCE OF THIS ISSUE. PER PROCEDURE THERMOPLASTIC OVERMOLDING OF PARTS SAMPLE SIZE: 100% WHILE PARTS ARE IN PROCESS: PERFORM A VISUAL INSPECTION TO VERIFY THE PARTS MEET APPLICABLE COSMETIC CRITERIA (E.G, FLASH, SHORT SHOTS, GATE BLUSH, FM, ETC.). PER QA PROCEDURE DESTINO DILATOR IN-PROCESS AND FINAL INSPECTION SAMPLE SIZE: 5 FIRST AND 5 LAST GOOD SHOTS INSPECT 100% VISUAL INSPECTION: HUB TO BE ROUND AND SMOOTH, NO IRREGULARITIES INSIDE. AT 12-18" DISTANCE, HUB SHAPE SHOULD BE AS PER DRAWING, FLASH <0.75 MM OR PINCH SHOULD NOT EXCEED 0.2 MM (USE PROFILE PROJECTOR IF NEEDED). MEASURE ID OF DILATOR HUB BY INSERTING APPROPRIATE PIN GAUGE THROUGH HUB. THE INSTRUCTIONS FOR USE (IFU) INFORMS THE USER: PLACE DILATOR INSIDE THE SHEATH AND SNAP ON BOTH HUBS TOGETHER. THREAD THE DILATOR/SHEATH ASSEMBLY OVER THE GUIDEWIRE, USING A SLIGHT TWISTING MOTION. 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. CORRECTIVE ACTIONS INITIATED TO INVESTIGATE AND MITIGATE THE REOCCURRENCE OF THIS ISSUE. 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 THIS TOURGUIDE DILATOR IS NOT CLICKING INTO THE GUIDE CATHETER HUB AT ALL. THIS IS NOT HOW THE PRODUCT LOOKED OR FELT LIKE BEFORE. THERE IS NO WAY TO GET THE DILATOR TO LOCK INTO ITS PLACE IN THE GUIDE AND THE DILATOR IS MOVING FREELY IN THE CATHETER. THE SLIGHTEST PUSH AT THE END OF THE DILATOR (MIMICKING VESSEL WALL IN CASE OF AN INSERTION) IS MAKING THE DILATOR SLIDE AWAY FROM THE GUIDE CATHETER. THIS DEVICE WAS NOT USED IN A PROCEDURE, ON A PATIENT, BY A PHYSICIAN OR BY A HEALTHCARE PROFESSIONAL. THE DEVICE INVOLVED IN THIS COMPLAINT WAS REPORTED FROM THE DISTRIBUTORS' REPRESENTATIVE, FROM THEIR OWN DEMONSTRATION DEVICE INVENTORY. ON (B)(6) 2023 THE CUSTOMER REPORTED THAT BEFORE MEETING WITH A CUSTOMER ON (B)(6) 2023, SHE ATTEMPTED TO USE HER DEMONSTRATION DEVICE AND DISCOVERED THE DEVICE WAS NOT WORKING CORRECTLY, AS STATED ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654968 TOURGUIDE¿ STEERABLE SHEATH INTRODUCER, CATHETER DYB OSCOR INC. TG0704509 DP-17035 00850232006055

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown