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

Description of Event or Problem

IT WAS REPORTED "(B)(6) 2025, BEFORE INSERTION, THE DOCTOR FOUND SWG KINKED PRIOR TO THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

Additional Manufacturer Narrative

QN# (B)(4).

Description of Event or Problem

IT WAS REPORTED "(B)(6) 2025, BEFORE INSERTION, THE DOCTOR FOUND SWG KINKED PRIOR TO THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

Additional Manufacturer Narrative

(B)(4). THE CUSTOMER RETURNED ONE GUIDE WIRE ASSEMBLY FOR ANALYSIS. SIGNS OF USE WERE OBSERVED ON THE GUIDE WIRE AND INSIDE THE TUBING ASSEMBLY, WHICH CONTRADICTS THE CUSTOMER REPORT THAT THE DEFECT WAS OBSERVED PRIOR TO USE. THE CUSTOMER WAS CONTACTED, AND THEY REITERATED THAT THE DEFECT WAS OBSERVED PRIOR TO USE AND ANY BIOLOGICAL MATERIAL IS FROM EXPOSURE WITHIN THE CLINICAL SETTING. THE GUIDE WIRE WAS REMOVED FROM THE TUBING AND A KINK WAS OBSERVED TOWARDS THE DISTAL END. MICROSCOPIC EXAMINATION CONFIRMED THE DAMAGE AND REVEALED THAT THE DISTAL J-BEND WAS SLIGHTLY MISSHAPEN. FURTHER MICROSCOPIC EXAMINATION REVEALED THAT THE DISTAL AND PROXIMAL WELDS WERE SECURE AND INTACT. WHEN ASSEMBLED INSIDE THE GUIDE WIRE TUBING, THE LOCATION OF THE KINK WOULD BE LOCATED INSIDE THE BLUE STRAIGHTENER TUBE, PROTECTING IT FROM DAMAGE WHILST INSIDE THE PACKAGING. THE KINK ON THE GUIDE WIRE MEASURED 655MM FROM THE PROXIMAL WELD. THE GUIDE WIRE TOTAL LENGTH MEASURED 683MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 678MM-688MM PER THE GUIDE WIRE PRODUCT DRAWING. THE GUIDE WIRE OUTER DIAMETER MEASURED 0.840MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.838MM-0.877MM PER THE GUIDE WIRE PRODUCT DRAWING. THE GUIDE WIRE WAS PASSED THROUGH A LAB INVENTORY ARROW RAULERSON SYRINGE (ARS) AND 18GA INTRODUCER NEEDLE. DESPITE THE KINKING, THE GUIDE WIRE WAS ABLE TO PASS THROUGH BOTH COMPONENTS WITH LITTLE TO NO ISSUE. 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 DISTAL AND PROXIMAL WELDS WERE 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 IF PACKAGE IS DAMAGED". THE IFU ALSO STATES, "DO NOT USE EXCESSIVE FORCE WHEN INTRODUCING GUIDEWIRE OR TISSUE DILATOR AS THIS CAN LEAD TO VESSEL PERFORATION, BLEEDING, OR COMPONENT DAMAGE". THE REPORT THAT THE GUIDEWIRE WAS KINKED WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. A KINK WAS OBSERVED TOWARDS THE DISTAL END OF THE GUIDEWIRE BODY. THE GUIDEWIRE MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. DURING NORMAL ASSEMBLY, THE KINKED PORTION OF THE GUIDEWIRE WOULD BE PROTECTED WITHIN THE GUIDEWIRE TUBING. BASED ON THE CUSTOMER REPORT AND SAMPLE RECEIVED, THE POTENTIAL ROOT CANNOT BE DETERMINED AS IT IS UNKNOWN IF THE DAMAGE OCCURRED BEFORE OR AFTER THE CUSTOMER HANDLED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.