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

Additional Manufacturer Narrative

QN#(B)(4). THE ACTUAL SAMPLE WAS NOT RETURNED; HOWEVER, THE CUSTOMER PROVIDED ONE PHOTO FOR ANALYSIS. THE COMPLAINT OF THE GUIDEWIRE BEING KINKED WAS ABLE TO BE CONFIRMED BY THE PHOTO. A RED CIRCLE SHOWS WHERE THE DAMAGE TO THE GUIDEWIRE IS LOCATED, WHICH APPEARS TO BE AT THE DISTAL END. A COMPLETE VISUAL INSPECTION COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT WARNS THE USER, "DO NOT APPLY EXCESSIVE FORCE IN PLACING OR REMOVING CATHETER OR GUIDEWIRE. EXCESSIVE FORCE CAN CAUSE COMPONENT DAMAGE OR BREAKAGE. IF DAMAGE IS SUSPECTED OR WITHDRAWAL CANNOT BE EASILY ACCOMPLISHED, RADIOGRAPHIC VISUALIZATION SHOULD BE OBTAINED AND FURTHER CONSULTATION REQUESTED." WITHOUT THE DEVICE TO EVALUATE, 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 "(B)(6) 2025, THE DOCTOR FOUND THE SWG KINKED DURING USE ON 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".

Description of Event or Problem

IT WAS REPORTED "ON (B)(6) 2025, THE DOCTOR FOUND THE SWG KINKED DURING USE ON 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).

Description of Event or Problem

IT WAS REPORTED "(B)(6) 2025, THE DOCTOR FOUND THE SWG KINKED DURING USE ON 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 PROVIDED ONE IMAGE FOR ANALYSIS. THE COMPLAINT OF A KINKED GUIDEWIRE WAS CONFIRMED BY THE PHOTO, WHICH SHOWS A GUIDEWIRE CONTAINING A KINK ON ITS DISTAL END. THE CUSTOMER ALSO RETURNED ONE SWG IN ITS ADVANCER, CATHETER, ARROW RAULERSON SYRINGE, NEEDLE, AND SCALPEL FOR EVALUATION. THE GUIDEWIRE HAD ONE KINK TOWARDS THE DISTAL J-BEND OF ITS BODY. SIGNS OF USE WERE OBSERVED ON THE GUIDEWIRE. THE DISTAL J-BEND WAS SLIGHTLY MISSHAPEN AND WAS INTACT. MICROSCOPIC EXAMINATION CONFIRMED THE DAMAGE AND REVEALED THAT THE DISTAL AND PROXIMAL WELDS WERE SECURE AND INTACT. THE KINK MEASURED 664MM FROM THE PROXIMAL TIP OF THE GUIDEWIRE. THE GUIDEWIRE LENGTH MEASURED 683MM , WHICH IS WITHIN THE SPECIFICATION LIMITS OF 678MM - 688MM PER THE GUIDEWIRE PRODUCT DRAWING. THE GUIDEWIRE OUTER DIAMETER MEASURED 0.84MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.838MM - 0.877MM PER THE GUIDEWIRE PRODUCT DRAWING. THE GUIDEWIRE WAS INSERTED THROUGH A LAB INVENTORY ARROW RAULERSON SYRINGE (ARS)/18GA INTRODUCER NEEDLE ASSEMBLY, AND IT WAS ABLE TO PASS WITH LITTLE TO NO DIFFICULTY AT THE UNDAMAGED PORTION. RESISTANCE WAS ENCOUNTERED AT THE LOCATION OF THE KINK. PERFORMED PER IFU STATEMENT , "RAISE THUMB AND PULL ARROW ADVANCER APPROXIMATELY 4 - 8 CM AWAY FROM ARROW RAULERSON SYRINGE OR INTRODUCER NEEDLE. LOWER THUMB ONTO ARROW ADVANCER AND WHILE MAINTAINING A FIRM GRIP ON GUIDEWIRE, PUSH ASSEMBLY INTO SYRINGE BARREL TO 4 FURTHER ADVANCE GUIDEWIRE. CONTINUE UNTIL GUIDEWIRE REACHES DESIRED DEPTH." A MANUAL TUG TEST CONFIRMED THAT THE DISTAL AND PROXIMAL WELDS WERE INTACT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT WARNS THE USER , "DO NOT APPLY EXCESSIVE FORCE IN PLACING OR REMOVING CATHETER OR GUIDEWIRE. EXCESSIVE FORCE CAN CAUSE COMPONENT DAMAGE OR BREAKAGE. IF DAMAGE IS SUSPECTED OR WITHDRAWAL CANNOT BE EASILY ACCOMPLISHED , RADIOGRAPHIC VISUALIZATION SHOULD BE OBTAINED AND FURTHER CONSULTATION REQUESTED." THE REPORT OF A KINKED GUIDEWIRE WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL ANALYSIS REVEALED ONE KINK ON THE GUIDEWIRE. THE GUIDEWIRE MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. BASED ON THE CUSTOMER REPORT THAT THE DAMAGE WAS OBSERVED DURING USE AND THE SAMPLE RECEIVED, UNINTENTIONAL USE ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.