ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 13 CM

Additional Manufacturer Narrative

(B)(4). THE ACTUAL DEVICE WAS NOT RETURNED; HOWEVER, THE CUSTOMER PROVIDED ONE PHOTO FOR ANALYSIS. THE COMPLAINT OF A KINKED GUIDEWIRE WAS ABLE TO BE CONFIRMED BY THE PHOTO. THE IMAGE SHOWS A GUIDEWIRE WITH KINKING TOWARDS THE DISTAL END, HOWEVER, A COMPLETE VISUAL INSPECTION TO DETERMINE THE CAUSE OF THE DAMAGE 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." THE CUSTOMER REPORT OF A KINKED GUIDEWIRE WAS CONFIRMED BY VISUAL INSPECTION OF THE CUSTOMER-SUPPLIED PHOTO. THE IMAGE SHOWS A GUIDEWIRE WITH KINKING TOWARDS THE DISTAL END, HOWEVER, FULL COMPLAINT VERIFICATION TESTING TO DETERMINE THE CAUSE OF THE DAMAGE COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. 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".

Additional Manufacturer Narrative

QN# (B)(4). THE CUSTOMER PROVIDED ONE IMAGE SHOWING ONE GUIDEWIRE. VISUAL ANALYSIS OF THE REMAINING GUIDEWIRE REVEALED THAT IT WAS BENT. THE CUSTOMER ALSO RETURNED ONE GUIDEWIRE FOR ANALYSIS. SIGNS OF USE WERE OBSERVED. VISUAL INSPECTION IDENTIFIED TWO KINKS NEAR THE DISTAL J-BEND, AND THE J-BEND WAS MISSHAPEN. MICROSCOPIC EXAMINATION CONFIRMED THE OBSERVED DAMAGE AND SHOWED THAT BOTH THE DISTAL AND PROXIMAL WELDS WERE FULL AND SPHERICAL. TWO KINKS ON THE GUIDEWIRE WERE LOCATED AT 567 MM AND 575 MM FROM THE PROXIMAL TIP. THE OVERALL LENGTH OF THE GUIDEWIRE MEASURED 601 MM, WHICH IS WITHIN THE SPECIFICATION OF 596-604 MM PER PRODUCT DRAWING. THE OUTER DIAMETER OF THE GUIDEWIRE MEASURED 0.860 MM, WHICH IS WITHIN THE SPECIFICATION OF 0.838-0.877 MM PER PRODUCT DRAWING. THE GUIDE WIRE WAS FUNCTIONALLY TESTED PER THE PRODUCT INSTRUCTIONS FOR USE (IFU). THE IFU PROVIDED WITH THIS KIT INSTRUCTS THE USER, "ADVANCE GUIDEWIRE INTO ARROW RAULERSON SYRINGE APPROXIMATELY 10 CM UNTIL IT PASSES THROUGH SYRINGE VALVES OR INTO INTRODUCER NEEDLE." THE GUIDEWIRE WAS ADVANCED THROUGH A LAB INVENTORY ARS AND AN 18GA LAB INVENTORY INTRODUCER NEEDLE TO PERFORM FUNCTIONAL TESTING. SLIGHT RESISTANCE WAS ENCOUNTERED WHEN THE KINKED AREA PASSED THROUGH THE ARS AND INTRODUCER NEEDLE, WHILE THE UNDAMAGED PORTIONS OF THE GUIDEWIRE ADVANCED WITH LITTLE NO RESISTANCE. A MANUAL TUG TEST CONFIRMED THAT BOTH THE DISTAL AND PROXIMAL WELDS WERE INTACT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THE KIT DESCRIBES SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF GUIDE WIRE DAMAGE DURING USE. THE INSTRUCTIONS CAUTION, "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 THAT THE GUIDEWIRE KINKED DURING USE WAS CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE. THE GUIDEWIRE EXHIBITED TWO KINKS NEAR THE DISTAL J-BEND, AND THE J-BEND WAS MISSHAPEN. THE GUIDEWIRE MET ALL RELEVANT DIMENSIONAL REQUIREMENTS. FUNCTIONAL TESTING CONFIRMED SLIGHT RESISTANCE AT THE KINKED AREA, WHILE UNDAMAGED PORTIONS OF THE GUIDEWIRE ADVANCED SMOOTHLY THROUGH THE ARS AND 18GA INTRODUCER NEEDLE, CONFIRMING FUNCTIONALITY ASIDE FROM USER-RELATED DAMAGE. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY MANUFACTURING-RELATED ISSUES. BASED ON THE CONDITION OF THE GUIDEWIRE AND THE REPORT THAT THE DAMAGE WAS OBSERVED DURING USE, THE LIKELY ROOT CAUSE IS CONSISTENT WITH UNINTENTIONAL USER ERROR. TELEFLEX WILL CONTINUE TO MONITOR AND TREND 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".

Additional Manufacturer Narrative

(B)(4)

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".