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

Description of Event or Problem

IT WAS REPORTED THAT DURING INITIAL INSERTION OF AN ARTERIAL CATHETER, THE SPRING WIRE GUIDE (SWG) UNRAVELED AND SEPARATED; HOWEVER, THE PROVIDER WAS ABLE TO RETRIEVE THE SWG IN ITS ENTIRETY FROM THE ARTERY. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT, THE PATIENT'S CONDITION WAS REPORTED AS "FINE," AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED BEYOND THAT DESCRIBED.

Additional Manufacturer Narrative

(B)(4). THE CUSTOMER RETURNED ONE GUIDEWIRE AND LIDSTOCK FOR ANALYSIS. VISUAL ANALYSIS OF THE GUIDEWIRE CONFIRMED THAT IT WAS SEPARATED INTO TWO PIECES. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WERE OBSERVED ON THE GUIDEWIRE BODY. MICROSCOPIC EXAMINATION CONFIRMED THE COIL WIRE SEPARATED AND REVEALED THAT THE POINT OF SEPARATION ON THE CORE WIRE WAS ADJACENT TO THE PROXIMAL WELD. THE CORE WIRE HAD A THIN, FLATTENED APPEARANCE AT THE POINT OF SEPARATION. THE DISTAL WELD WAS STILL INTACT. BOTH WELDS APPEARED FULL AND SPHERICAL. BOTH PIECES OF THE CORE WIRE WERE MEASURED 13 3/4" WHICH IS WITHIN THE SPECIFICATION LIMITS OF 13 25/32" - 14" PER THE GUIDEWIRE PRODUCT DRAWING. THIS CONFIRMS THAT ALL OF THE CORE WIRE WAS REMOVED FROM THE PATIENT. THE GUIDEWIRE OUTER DIAMETER MEASURED 0.0240" WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.0240" - 0.0250" PER THE GUIDEWIRE PRODUCT DRAWING. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED SAMPLE. A MANUAL TUG TEST CONFIRMED THAT THE DISTAL WELD WAS INTACT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THIS KIT INFORMS THE USER, "WARNING: TO REDUCE THE RISK OF GUIDEWIRE DAMAGE, DO NOT RETRACT GUIDEWIRE AGAINST EDGE OF NEEDLE WHILE IN VESSEL." THE CUSTOMER REPORT OF A SEPARATED GUIDEWIRE DURING USE WAS CONFIRMED THROUGH INVESTIGATION OF THE RETURNED SAMPLE. VISUAL ANALYSIS OF THE GUIDEWIRE CONFIRMED THAT IT WAS SEPARATED INTO TWO PIECES. MICROSCOPIC EXAMINATION REVEALED THAT THE POINT OF SEPARATION ON THE CORE WIRE WAS ADJACENT TO THE PROXIMAL WELD. DIMENSIONAL INSPECTION AND A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY EVIDENCE OF A MANUFACTURING RELATED ISSUE. ARROW GUIDEWIRES OF THIS SIZE ARE DESIGNED AND MANUFACTURED TO WITHSTAND A TENSILE FORCE OF 2.75 POUNDS FORCE. THIS INTERNAL SPECIFICATION IS HIGHER THAN THE BS EN ISO 11070:2014 STANDARD OF 1.1 POUNDS FORCE FOR THIS SIZE WIRE. THE SELECTED INSERTION SITE AND PATIENT ANATOMY MAY PRESENT A TORTUOUS PATH THAT COULD CONTRIBUTE TO THE POSSIBILITY OF GUIDE WIRE KINKING. GUIDEWIRE BREAKAGE MAY OCCUR IF A FORCE GREATER THAN THE DESIGN SPECIFICATION IS APPLIED DURING REMOVAL. BASED ON THESE CIRCUMSTANCES, UNINTENTIONAL USE ERROR LIKELY CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.