ARROW RA CATH SET: 22 GA X 1-3/8IN

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT "A VERY EXPERIENCED DR WAS INSERTING INTO A PEDS PATIENT. HE ADVANCED THE WIRE AND WHILE MANIPULATING HE COULD TELL SOMETHING WAS NOT RIGHT. HE PULLED THE WHOLE DEVICE OUT AND THE WIRE SHEARED AND UNWOUND IN THE PATIENT. SOME OF THE WIRE WAS LEFT IN THE PATIENT. THEY WERE ABOUT TO DO A CUT DOWN TO REMOVE THE RETAINED WIRE WHEN THEY SAW A LITTLE THREAD STICKING OUT OF THE SKIN." THEY WERE ABLE TO GRASP IT AND REMOVE ALL OF THE RETAINED WIRE." THERE WAS A DELAY TO THE PROCEDURE. ANOTHER DEVICE WAS USED. 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). THE ACTUAL DEVICE WAS NOT RETURNED; HOWEVER, THE CUSTOMER PROVIDED TWO PHOTOS FOR ANALYSIS. THE COMPLAINT OF A SEPARATED GUIDE WIRE WAS CONFIRMED BY THE PHOTOS; HOWEVER, A COMPLETE VISUAL INSPECTION COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER; THEREFORE, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED UPON A LOT NUMBER TAKEN FROM THE SALES HISTORY DATA OF THE CUSTOMER. NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "TO REDUCE THE RISK OF GUIDEWIRE DAMAGE, DO NOT RETRACT GUIDE WIRE AGAINST EDGE OF NEEDLE WHILE IN VESSEL". THE IFU ALSO STATES, "IF RESISTANCE IS ENCOUNTERED DURING GUIDEWIRE ADVANCEMENT DO NOT FORCE FEED, WITHDRAW ENTIRE UNIT AND ATTEMPT NEW PUNCTURE". ARROW GUIDE WIRES OF THIS SIZE ARE DESIGNED AND MANUFACTURED TO WITHSTAND A TENSILE FORCE OF 1.5 POUNDS FORCE. THE SELECTED INSERTION SITE AND PATIENT ANATOMY MAY PRESENT A TORTUOUS PATH THAT COULD CONTRIBUTE TO THE POSSIBILITY OF GUIDE WIRE KINKING. GUIDE WIRE BREAKAGE MAY OCCUR IF A FORCE GREATER THAN THE DESIGN SPECIFICATION IS APPLIED DURING REMOVAL. BASED ON THESE CIRCUMSTANCES, THE APPEARANCE OF THE DAMAGE IS CONSISTENT WITH UNDUE FORCE APPLIED DURING INSERTION; HOWEVER, THIS CANNOT BE CONFIRMED WITHOUT THE SAMPLE RETURNED FOR ANALYSIS. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE

Description of Event or Problem

IT WAS REPORTED THAT "A VERY EXPERIENCED DR WAS INSERTING INTO A PEDS PATIENT. HE ADVANCED THE WIRE AND WHILE MANIPULATING HE COULD TELL SOMETHING WAS NOT RIGHT. HE PULLED THE WHOLE DEVICE OUT AND THE WIRE SHEARED AND UNWOUND IN THE PATIENT. SOME OF THE WIRE WAS LEFT IN THE PATIENT. THEY WERE ABOUT TO DO A CUT DOWN TO REMOVE THE RETAINED WIRE WHEN THEY SAW A LITTLE THREAD STICKING OUT OF THE SKIN." THEY WERE ABLE TO GRASP IT AND REMOVE ALL OF THE RETAINED WIRE." THERE WAS A DELAY TO THE PROCEDURE. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".