HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM

Additional Manufacturer Narrative

(B)(4). THE CUSTOMER RETURNED ONE GUIDEWIRE ASSEMBLY AND ARROW RAULERSON SYRINGE (ARS) FOR ANALYSIS. THE GUIDEWIRE WAS RETURNED WITHIN THE ADVANCER AND SIGNS OF USE WERE OBSERVED. FUNCTIONAL INSPECTION OF THE GUIDEWIRE WAS PERFORMED PER THE PRODUCT INSTRUCTIONS-FOR-USE (IFU), WHICH STATES, "ADVANCE GUIDEWIRE INTO ARROW RAULERSON SYRINGE APPROXIMATELY 10 CM UNTIL IT PASSES THROUGH SYRINGE VALVES OR INTO INTRODUCER NEEDLE" THE GUIDEWIRE WAS INSERTED THROUGH THE RETURNED ARS AND LAB INVENTORY 18-GA INTRODUCER NEEDLE AND ADVANCED. RESISTANCE WAS ENCOUNTERED AT THE LOCATION OF THE KINK. THE UNDAMAGED PORTION PASSED WITH LITTLE TO NO RESISTANCE. A MANUAL TUG TEST CONFIRMED THE DISTAL AND PROXIMAL WELDS WERE INTACT. THE REPORT OF A KINKED GUIDEWIRE WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. VISUAL INSPECTION REVEALED ONE KINK TOWARDS THE CENTER OF THE GUIDEWIRE. DESPITE THIS, THE GUIDEWIRE AND ARS MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. BASED ON THESE CIRCUMSTANCES, UNINTENTIONAL USE ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

Description of Event or Problem

IT WAS REPORTED THAT: "(B)(6) 2025, THE OCCLUSION OF THE CENTRAL LUMEN OF ARS PREVENTED THE GUIDEWIRE FROM PASSING THROUGH SMOOTHLY, RESULTING IN GUIDEWIRE DEFLECTION AND KINKING. THE SAME ISSUE PERSISTED EVEN AFTER THE CATHETER WAS REPLACED. THE SECOND SWG AND ARS WERE USED ON THE PATIENT. ALTHOUGH THERE IS RESISTANCE, THE DOCTOR ADJUSTED THE PUNCTURE ANGLE AND THE PROCEDURE WAS ULTIMATELY COMPLETED SUCCESSFULLY. NO THIRD SWG AND ARS WERE USED. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."