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

Description of Event or Problem

IT WAS REPORTED THAT: "ON (B)(6) 2026, DURING INSERTION, THE SWG WAS FOUND KINKED DURING USED ON THE PATIENT. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE.NO MEDICAL INTERVENTION WAS REQUIRED.THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE."

Additional Manufacturer Narrative

(B)(4). THE CUSTOMER PROVIDED ONE PHOTO FOR ANALYSIS: THE PHOTO SHOWS GUIDEWIRE IN A KINKED CONDITION WITH A MISSHAPEN J-BAND. THE GUIDEWIRE ALSO APPEARS POSITIONED WITHIN THE ADVANCER OF THE GUIDEWIRE TUBE ASSEMBLY. THE CUSTOMER RETURNED ONE GUIDEWIRE AND 2-LUMEN 12 FR X 20 CM CATHETER FOR ANALYSIS. SIGNS OF USE WERE OBSERVED ON THE GUIDEWIRE AND CATHETER. FOUR KINKS WERE IDENTIFIED ON THE GUIDEWIRE BODY, ONE OF KINK WAS LOCATED TOWARDS THE J-BEND REGION AND ANOTHER WAS OBSERVED TOWARDS PROXIMAL END. THE DISTAL J-BEND WAS MISHAPPENED. MICROSCOPIC EXAMINATION CONFIRMED THAT PROXIMAL AND DISTAL WELDS WERE PRESENT AND APPEARED FULL AND SPHERICAL. THE GUIDEWIRE WAS FUNCTIONALLY TESTED IN ACCORDANCE WITH THE PRODUCT INSTRUCTIONS FOR USE (IFU). THE IFU PROVIDED WITH THIS KIT INSTRUCTS THE USER TO "ADVANCE THE GUIDEWIRE INTO THE ARROW RAULERSON SYRINGE APPROXIMATELY 10 CM UNTIL IT PASSES THROUGH THE SYRINGE VALVES OR INTO THE INTRODUCER NEEDLE." FUNCTIONAL TESTING WAS PERFORMED BY ADVANCING THE GUIDEWIRE THROUGH A LABORATORY INVENTORY ARROW RAULERSON SYRINGE (ARS) AND A LABORATORY INVENTORY 18-GAUGE INTRODUCER NEEDLE. RESISTANCE WAS OBSERVED AT THE KINKED LOCATIONS; HOWEVER, THE UNDAMAGED PORTIONS OF THE GUIDEWIRE ADVANCED THROUGH THE ARS AND INTRODUCER NEEDLE WITHOUT RESISTANCE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE INSTRUCTIONS-FOR-USE (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 WAS OBSERVED TO BE KINKED DURING USE WAS CONFIRMED THROUGH INVESTIGATION OF THE RETURNED SAMPLE. VISUAL EXAMINATION IDENTIFIED FOUR KINKS WERE IDENTIFIED ON THE GUIDEWIRE BODY, ONE OF KINK WAS LOCATED TOWARDS THE J-BEND REGION AND ANOTHER WAS OBSERVED TOWARD PROXIMAL END. THE DISTAL J-BEND WAS MISHAPPEN. SIGNS OF USE WERE OBSERVED ON THE RETURNED GUIDEWIRE. THE RETURNED GUIDE WIRE MET ALL RELEVANT DIMENSIONAL/FUNCTIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY MANUFACTURING-RELATED ISSUES. BASED ON THE CONDITION OF THE GUIDE WIRE AND THE REPORT THAT THE DAMAGE WAS OBSERVED DURING USE, UNINTENTIONAL USE ERROR CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.