ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM

Additional Manufacturer Narrative

(B)(4) THE CUSTOMER RETURNED ONE GUIDE WIRE ASSEMBLY AND AN 18GA INTRODUCER NEEDLE FOR ANALYSIS. THE GUIDE WIRE WAS RETURNED INSERTED THROUGH THE NEEDLE CANNULA. SIGNS OF USE WERE OBSERVED INSIDE THE NEEDLE HUB. VISUAL ANALYSIS REVEALED THAT THE GUIDE WIRE WAS UNRAVELED FROM THE DISTAL END. FURTHER ANALYSIS REVEALED THAT THE GUIDE WIRE COIL WIRE WAS ADVANCED PAST THE NEEDLE BEVEL; HOWEVER, THE GUIDE WIRE CORE WIRE WAS LOCATED PROXIMAL TO THE NEEDLE HUB. THIS INDICATES THAT THE GUIDE WIRE WAS INITIALLY ADVANCED PAST THE BEVEL BUT WAS THEN RETRACTED. THE GUIDE WIRE WAS GENTLY REMOVED FROM THE CANNULA AND DRIED BIOLOGICAL MATERIAL WAS OBSERVED ON THE COILS. MICROSCOPIC EXAMINATION CONFIRMED THE DAMAGE AND REVEALED THAT THE CORE WIRE SEPARATED DIRECTLY ADJACENT TO THE DISTAL WELD. THE DISTAL AND PROXIMAL WELDS APPEARED FULL AND SPHERICAL. THE GUIDE WIRE LENGTH FROM THE PROXIMAL WELD TO THE POINT OF SEPARATION ON THE CORE WIRE MEASURED 70.3CM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 69.4CM-70.6CM PER THE GUIDE WIRE PRODUCT DRAWING. THE GUIDE WIRE OUTER DIAMETER MEASURED 0.945MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.940MM-0.965MM PER THE GUIDE WIRE PRODUCT DRAWING. THE NEEDLE CANNULA OUTER DIAMETER MEASURED 0.0496", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.0495"-0.0505" PER THE CANNULA PRODUCT DRAWING. THE CANNULA INNER DIAMETER MEASURED 0.041", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.041"-0.043" PER THE CANNULA PRODUCT DRAWING. A LAB INVENTORY GUIDE WIRE (OUTER DIAMETER MEASURED 0.0373") WAS INSERTED THROUGH THE CANNULA. NO RESISTANCE WAS ENCOUNTERED AS THE GUIDE WIRE PASSED COMPLETELY THROUGH THE CANNULA. PERFORMED PER IFU STATEMENT, "ADVANCE GUIDEWIRE INTO ARROW RAULERSON SYRINGE APPROXIMATELY 10 CM UNTIL IT PASSES THROUGH SYRINGE VALVES OR INTO INTRODUCER NEEDLE". A MANUAL TUG TEST CONFIRMED THAT THE PROXIMAL WELD WAS SECURE AND INTACT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "DO NOT USE EXCESSIVE FORCE WHEN INTRODUCING GUIDEWIRE OR TISSUE DILATOR AS THIS CAN LEAD TO VESSEL PERFORATION, BLEEDING, OR COMPONENT DAMAGE". THE IFU ALSO STATES, "DO NOT WITHDRAW GUIDEWIRE AGAINST NEEDLE BEVEL TO REDUCE RISK OF POSSIBLE SEVERING OR DAMAGING OF GUIDEWIRE". THE REPORT THAT THE GUIDE WIRE UNRAVELED WAS CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE. THE CORE WIRE WAS BROKEN ADJACENT TO THE DISTAL WELD. THE GUIDE WIRE AND CANNULA MET ALL FUNCTIONAL/DIMENSIONAL REQUIREMENTS DURING INVESTIGATION TESTING. NO MANUFACTURING DEFECTS WERE FOUND DURING THIS INVESTIGATION. ARROW GUIDE WIRES OF THIS SIZE ARE DESIGNED AND MANUFACTURED TO WITHSTAND A TENSILE FORCE OF 2.75 POUNDS FORCE. THE SELECTED INSERTION SITE AND PATIENT ANATOMY MAY PRESENT A TORTUOUS PATH THAT COULD CONTRIBUTE TO THE POSSIBILITY OF GUIDE WIRE KINKING. GUIDE WIRE BREAKAGE MAY OCCUR IF A FORCE GREATER THAN THE DESIGN SPECIFICATION IS APPLIED DURING REMOVAL. BASED ON THESE CIRCUMSTANCES, 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 " DURING DYALISE CATHETER INSERTION, THE GUIDE WAS BLOCKED IN THE TROCAR. ONE OF THE 2 GUIDE IS UNRAVELLED AND DAMAGED." THE PATIENT'S CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL QUESTIONS WAS ASKED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED " DURING DYALISE CATHETER INSERTION, THE GUIDE WAS BLOCKED IN THE TROCAR. ONE OF THE 2 GUIDE IS UNRAVELLED AND DAMAGED." THE PATIENT'S CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL QUESTIONS WAS ASKED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME.

Additional Manufacturer Narrative

(B)(4).