ARROW RA CATH SET: 20 GA X 1-3/4IN

Additional Manufacturer Narrative

(B)(4). THE CUSTOMER RETURNED ONE CATHETERIZATION DEVICE FOR ANALYSIS. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WERE FOUND ON THE INTERIOR OF THE DEVICE. BENDING AND KINKS WERE OBSERVED ON THE GUIDE TUBE. THE GUIDEWIRE WAS FULLY ADVANCED, AND THE DISTAL WELD WAS MISSING. THE SEPARATED PORTION (INCLUDING DISTAL WELD) WAS NOT RETURNED WITH THE SAMPLE. THE CATHETER HAD BEEN ADVANCED OFF THE NEEDLE CANNULA AND WAS NOT RETURNED FOR EVALUATION. THE INNER DIAMETER OF THE NEEDLE CANNULA MEASURED 0.0190", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.0190" - 0.0205" PER THE CANNULA PRODUCT DRAWING. THE GUIDEWIRE LENGTH FROM THE PROXIMAL WELD TO THE POINT OF SEPARATION ON THE CORE WIRE MEASURED 136 MM, WHICH INDICATES THAT BETWEEN UP TO 3 MM OF THE GUIDEWIRE WAS SEVERED AND NOT RETURNED PER GUIDEWIRE PRODUCT DRAWING. THE OUTER DIAMETER OF THE UNDAMAGED PORTION OF THE GUIDEWIRE MEASURED 0.440 MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.432 MM - 0.457 MM PER GUIDEWIRE PRODUCT DRAWING. DIMENSIONAL INSPECTION OF THE CATHETER COULD NOT BE PERFORMED AS IT WAS NOT RETURNED. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE SEVERITY OF THE DAMAGE. A DEVICE HISTORY RECORD REVIEW, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "WARNING: TO REDUCE THE RISK OF GUIDEWIRE DAMAGE, DO NOT RETRACT GUIDEWIRE AGAINST EDGE OF NEEDLE WHILE IN VESSEL." THE REPORT OF A SEPARATED GUIDEWIRE WAS CONFIRMED THROUGH INVESTIGATION OF THE RETURNED SAMPLE. VISUAL ANALYSIS REVEALED THAT THE GUIDEWIRE HAD SEPARATED AND PARTIALLY UNRAVELED. THE OBSERVED DAMAGE IS CONSISTENT WITH UNDUE FORCE AND/OR CONTACT WITH THE NEEDLE BEVEL DURING GUIDEWIRE RETRACTION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. ARROW GUIDEWIRES OF THIS SIZE ARE DESIGNED AND MANUFACTURED TO WITHSTAND A TENSILE FORCE OF 2.0 POUNDS FORCE. THE SELECTED INSERTION SITE AND PATIENT ANATOMY MAY PRESENT A TORTUOUS PATH THAT COULD CONTRIBUTE TO THE POSSIBILITY OF GUIDEWIRE DAMAGE. GUIDEWIRE BREAKAGE MAY OCCUR IF A FORCE GREATER THAN THE DESIGN SPECIFICATION IS APPLIED DURING REMOVAL. BASED ON THESE CIRCUMSTANCES, 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 DURING INITIAL INSERTION OF AN ARTERIAL CATHETER, THE SPRING WIRE GUIDE (SWG) UNCOILED UPON ATTEMPTED RETRACTION. DURING THIS PROCESS, A FRAGMENT SEPARATED FROM THE SWG AND WAS IDENTIFIED SUBCUTANEOUSLY IN THE PATIENT. ADDITIONAL INFORMATION INDICATED THAT THE OPERATING PHYSICIAN EXPERIENCED DIFFICULTY RETRACTING THE SWG DURING INSERTION. AN ULTRASOUND EXAMINATION WAS PERFORMED, WHICH CONFIRMED THAT THE SEPARATED FRAGMENT WAS NOT LOCATED WITHIN THE ARTERIAL VESSEL. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE." NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED BEYOND THAT DESCRIBED.