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. AN INTRODUCER NEEDLE WAS CONNECTED TO THE GUIDEWIRE STRAIGHTENER TUBE AND THE GUIDEWIRE WAS ADVANCED THROUGH THE NEEDLE. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL INSIDE OF THE STRAIGHTENER TUBE, IN THE NEEDLE HUB, AND ON THE GUIDEWIRE WERE OBSERVED. THE GUIDEWIRE WAS OBSERVED TO BE KINKED ADJACENT TO DISTAL TIP OF THE NEEDLE CANNULA. 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. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. 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 CENTER OF THE BODY. THE RETURNED GUIDEWIRE MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS. 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IT WAS REPORTED THAT "THE GUIDEWIRE COULD NOT BE WITHDRAWN. THE PATIET WAS REPORTED AS FINE." THE DEVICE WAS FOUND TO BE KINKED ON RETURN TO MANUFACTURER.