BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 3-LUMEN 7 FR X 16 CM

    MDR report key: 19259064 · Received May 7, 2024

    Report

    Report Number
    3006425876-2024-00428
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Date of Event
    April 9, 2024
    Report Date
    April 10, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    UDI-DI
    10801902105223
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER PROVIDED ONE PHOTO FOR ANALYSIS. THE PHOTO SHOWS A KINKED GUIDE WIRE WITHIN THE THUMB GUIDE COMPONENT; HOWEVER, THE GUIDE WIRE ASSEMBLY TUBING (EBZ-15703-009), STRAIGHTENER TUBE (A-25854-006A), AND GUIDE WIRE CAP (A-25854-004A) WERE NOT PICTURED. THE CUSTOMER RETURNED ONE, OPENED CVC KIT INCLUDING THE GUIDE WIRE WITHIN ITS ADVANCER FOR ANALYSIS. THE GUIDE WIRE CAP AND STRAIGHTENER TUBE WERE NOT RETURNED. SIGNS OF USE WERE OBSERVED ON THE SAMPLE; HOWEVER, THE CUSTOMER STATED THE DEFECT IN THE GUIDE WIRE WAS NOT OBSERVED IN A CLINICAL SETTING. VISUAL ANALYSIS OF THE GUIDE WIRE REVEALED TWO KINKS TOWARDS THE DISTAL END. MICROSCOPIC EXAMINATION CONFIRMED THE KINKS IN THE GUIDE WIRE BODY. BOTH WELDS WERE PRESENT AND WERE OBSERVED TO BE FULL AND SPHERICAL. NO DEFECTS OR ANOMALIES WERE OBSERVED ON THE RETURNED PACKAGING. THE KINKS IN THE GUIDE WIRE MEASURED 411 MM AND 419 MM FROM THE PROXIMAL TIP. THE OVERALL LENGTH OF THE GUIDE WIRE MEASURED 451 MM WHICH IS WITHIN THE SPECIFICATION LIMITS OF 450-458 MM PER GUIDE WIRE PRODUCT DRAWING. THE OUTER DIAMETER OF THE GUIDE WIRE MEASURED 0.806 MM WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.788-0.826 MM PER GUIDE WIRE PRODUCT DRAWING. THE GUIDE WIRE WAS FUNCTIONALLY TESTED PER THE INSTRUCTIONS-FOR-USE (IFU). THE IFU PROVIDED WITH THIS KIT INSTRUCTS THE USER, "ADVANCE GUIDEWIRE INTO ARROW RAULERSON SYRINGE APPROXIMATELY 10 CM UNTIL IT PASSES THROUGH SYRINGE VALVES OR INTO INTRODUCER NEEDLE." AN ARROW RAULERSON SYRINGE IS NOT INCLUDED IN FINISHED GOOD CV-12703; THEREFORE, THE GUIDE WIRE WAS ADVANCED THROUGH A LAB INVENTORY 18GA INTRODUCER NEEDLE. THE UNDAMAGED PORTIONS OF THE GUIDE WIRE PASSED THROUGH WITH LITTLE TO NO RESISTANCE. A MANUAL TUG TEST CONFIRMED THAT BOTH THE DISTAL AND PROXIMAL WELDS WERE INTACT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THIS KIT WARNS THE USER, "DO NOT USE IF PACKAGE IS DAMAGED. DO NOT APPLY EXCESSIVE FORCE IN PLACING OR REMOVING CATHETER OR GUIDEWIRE. EXCESSIVE FORCE CAN CAUSE COMPONENT DAMAGE OR BREAKAGE.". THE REPORT THAT THE GUIDE WIRE WAS KINKED WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. TWO KINKS WERE OBSERVED TOWARDS THE DISTAL END OF THE GUIDE WIRE BODY. THE GUIDE WIRE MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS TO SUGGEST A MANUFACTURING RELATED CAUSE. THE PORTION OF THE GUIDE WIRE THAT WAS KINKED WOULD HAVE BEEN PROTECTED WITHIN THE ASSEMBLY TUBING DURING PACKAGING, STORAGE, AND SHIPPING, SO IT CANNOT BE CONFIRMED WHEN THE GUIDE WIRE WAS DAMAGED. IN ADDITION, THE SOURCE OF THE SIGNS OF USE OBSERVED ON THE SAMPLE COULD NOT BE VERIFIED. BASED ON THESE CIRCUMSTANCES, THE ROOT CAUSE OF THIS INVESTIGATION IS UNDETERMINED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4)

    Description of Event or Problem · 0

    IT WAS REPORTED "THE BROKEN GUIDEWIRE WAS FOUND WHILE OPENING THE PACKING OF PRODUCT." ANOTHER SET WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THEREFORE NO PATIENT HARM OR INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED "THE BROKEN GUIDEWIRE WAS FOUND WHILE OPENING THE PACKING OF PRODUCT." ANOTHER SET WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THEREFORE NO PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621418 ARROW CVC SET: 3-LUMEN 7 FR X 16 CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL LLC 71F23E1114 10801902105223

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NONE REPORTED| NONE REPORTED