ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM

Additional Manufacturer Narrative

(B)(4). THE CUSTOMER RETURNED ONE GUIDEWIRE ASSEMBLY WITH THE GUIDEWIRE ADVANCED WITHIN THE TUBING. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL INSIDE OF THE STRAIGHTENER TUBE AND ON THE GUIDEWIRE WERE OBSERVED. THE GUIDEWIRE WAS OBSERVED TO BE KINKED TOWARDS THE DISTAL TIP. THE DISTAL J-BEND WAS SLIGHTLY MISSHAPEN BUT INTACT. MICROSCOPIC EXAMINATION CONFIRMED THE KINKS IN THE GUIDEWIRE BODY. BOTH WELDS WERE PRESENT AND WERE OBSERVED TO BE FULL AND SPHERICAL. THE GUIDEWIRE WAS ADVANCED THROUGH A LAB INVENTORY ARS AND A LAB INVENTORY 18GA INTRODUCER NEEDLE TO FUNCTIONALLY TEST THE GUIDEWIRE. THE GUIDE WIRE PASSED THROUGH BOTH COMPONENTS WITH MINIMAL RESISTANCE. MAJOR RESISTANCE WAS OBSERVED AT THE KINKING; HOWEVER, THE UNDAMAGED PORTION OF THE GUIDEWIRE WAS ABLE TO PASS AS EXPECTED. BOTH TESTS PERFORMED PER IFU, "USING THUMB, RETRACT 'J'. PLACE TIP OF ARROW ADVANCER - WITH 'J' RETRACTED - INTO THE HOLE IN REAR OF ARROW RAULERSON SYRINGE PLUNGER OR INTRODUCER NEEDLE." THE REPORT THAT THE GUIDEWIRE KINKED DURING USE WAS CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE. THE GUIDEWIRE WAS KINKED IN TWO LOCATIONS TOWARDS THE DISTAL TIP. THE RETURNED GUIDEWIRE MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY MANUFACTURING RELATED ISSUES. BASED ON THE CONDITION OF THE GUIDEWIRE AND THE REPORT THAT THE DAMAGE WAS OBSERVED DURING USE, UNINTENTIONAL USE ERROR CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

Description of Event or Problem

IT WAS REPORTED THAT: "THE GUIDE WIRE COULD NOT BE REMOVED. THE DEVICE WAS RETURNED TO THE MANUFACTURER AND WAS FOUND TO BE KINKED".