ARROW ARTERIAL CATHETER KIT: 18 GA X 16 CM

Additional Manufacturer Narrative

(B)(4). THE REPORT THAT THE GUIDEWIRE KINKED DUE TO RESISTANCE WITH THE CATHETER WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE GUIDEWIRE HAD MULTIPLE KINKS TOWARDS THE CENTER AND DISTAL END OF THE BODY. THE CATHETER HAD KINKS THROUGHOUT THE BODY WHICH ALIGNED WITH THE KINKING IN THE GUIDEWIRE. THE RETURNED GUIDEWIRE AND CATHETER MET ALL RELEVANT DIMENSIONAL/FUNCTIONAL REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. BASED ON THE CONDITION OF THE GUIDEWIRE 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.

Description of Event or Problem

IT WAS REPORTED "WIRE MALFUNCTION". ADDITIONAL INFORMATION RECEIVED STATES " ADDITIONAL INFORMATION RECIEVED STATES "UNABLE TO THREAD CATHETER OVER WIRE ON REMOVAL OF WIRE. NOTICABLE KINK IN THE WIRE". THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN" AT THIS TIME.

Additional Manufacturer Narrative

(B)(4)

Description of Event or Problem

IT WAS REPORTED "WIRE MALFUNCTION". ADDITIONAL INFORMATION RECEIVED STATES " ADDITIONAL INFORMATION RECEIVED STATES "UNABLE TO THREAD CATHETER OVER WIRE ON REMOVAL OF WIRE. NOTICABLE KINK IN THE WIRE". THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN" AT THIS TIME.