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

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 OFFSET COILS AT ITS DISTAL END. THE CUSTOMER ALSO RETURNED ONE SWG IN ITS ADVANCER, CATHETER, ARROW RAULERSON SYRINGE (ARS), NEEDLE, DILATOR , AND SCALPEL FOR EVALUATION. THE GUIDEWIRE HAD KINKS ALONG ITS BODY. SIGNS OF USE WERE OBSERVED ON THE GUIDEWIRE. THE DISTAL J-BEND WAS SLIGHTLY MISSHAPEN. MICROSCOPIC EXAMINATION CONFIRMED THE DAMAGE AND REVEALED THAT THE DISTAL AND PROXIMAL WELDS WERE SECURE AND INTACT. THE KINKS MEASURED 633MM AND 640MM FROM THE PROXIMAL TIP OF THE GUIDEWIRE. THE GUIDEWIRE LENGTH MEASURED 685MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 678MM - 688MM PER THE GUIDEWIRE PRODUCT DRAWING. THE GUIDEWIRE OUTER DIAMETER MEASURED 0.85MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.838MM - 0.877MM PER THE GUIDEWIRE PRODUCT DRAWING. THE GUIDEWIRE WAS INSERTED THROUGH THE RETURNED ARROW RAULERSON SYRINGE (ARS)/18GA INTRODUCER NEEDLE ASSEMBLY, AND IT WAS ABLE TO PASS WITH LITTLE TO NO DIFFICULTY AT THE UNDAMAGED PORTION. MAJOR RESISTANCE WAS ENCOUNTERED AT THE DISTAL END, WHERE THE COILS WERE OFFSET. HOWEVER, THE GUIDEWIRE STILL PASSED WITH APPLIED FORCE. ADDITIONALLY, THE GUIDEWIRE WAS INSERTED WITH THE PROXIMAL END FIRST. NO RESISTANCE WAS ENCOUNTERED. 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 KINKING AND OFFSET COILS 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.

Description of Event or Problem

IT WAS REPORTED THAT"(B)(6) 2025, THE DOCTOR FOUND 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 THAT"(B)(6) 2025, THE DOCTOR FOUND 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".