ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT: "THE OCCLUSION OF THE CENTRAL LUMEN OF ARS PREVENTED THE GUIDEWIRE FROM PASSING THROUGH SMOOTHLY, RESULTING IN GUIDEWIRE DEFLECTION. THE SAME ISSUE PERSISTED EVEN AFTER THE CATHETER WAS REPLACED, YET THE PROCEDURE WAS ULTIMATELY COMPLETED SUCCESSFULLY. THE SECOND SWG/ARS THAT HAD RESISTANCE BUT WAS ABLE TO COMPLETE THE PROCEDURE WAS FOUND KINKED. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE." ASSOCIATED COMPLAINT 3006425876-2026-00050.

Additional Manufacturer Narrative

(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND POTENTIAL FINDINGS WERE IDENTIFIED; HOWEVER, AS NO SAMPLE WAS RETURNED FOR INVESTIGATION, IT COULD NOT BE DETERMINED IF THE FINDINGS WERE RELEVANT TO THE REPORTED EVENT. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

Description of Event or Problem

IT WAS REPORTED THAT: ", THE OCCLUSION OF THE CENTRAL LUMEN OF ARS PREVENTED THE GUIDEWIRE FROM PASSING THROUGH SMOOTHLY, RESULTING IN GUIDEWIRE DEFLECTION. THE SAME ISSUE PERSISTED EVEN AFTER THE CATHETER WAS REPLACED, YET THE PROCEDURE WAS ULTIMATELY COMPLETED SUCCESSFULLY. THE SECOND SWG/ARS THAT HAD RESISTANCE BUT WAS ABLE TO COMPLETE THE PROCEDURE WAS FOUND KINKED. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE." ASSOCIATED COMPLAINT 3006425876-2026-00108 AND 3006425876-2026-00050.