ARROW ARTERIAL CATH SET:18 GA CATH/20 GA NDL

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DURING AN ATTEMPTED PLACEMENT OF A 20-GAUGE ARTERIAL INTEGRATED GUIDEWIRE CATHETER SYSTEM IN THE LEFT FEMORAL ARTERY UNDER ULTRASOUND GUIDANCE, RESISTANCE WAS ENCOUNTERED AFTER PARTIAL INSERTION OF THE DEVICE, AND FURTHER ADVANCEMENT WAS IMMEDIATELY DISCONTINUED. SUBSEQUENT ATTEMPTS TO WITHDRAW THE DEVICE WERE MET WITH PERSISTENT RESISTANCE. DURING CAREFUL TRACTION, THE SPRING WIRE GUIDE (SWG) REPORTEDLY DEFORMED AND SHEARED, RESULTING IN RETENTION OF A WIRE SEGMENT WITHIN THE ARTERIAL VESSEL. BEDSIDE ULTRASOUND DEMONSTRATED AN ECHOGENIC LINEAR STRUCTURE WITHIN THE WALL OF THE LEFT FEMORAL ARTERY, CONSISTENT WITH A RETAINED GUIDEWIRE SEGMENT, WHICH APPEARED TO BE ADJACENT TO THE TUNICA MEDIA. NO IMMEDIATE EVIDENCE OF ACTIVE EXTRAVASATION, PSEUDOANEURYSM, OR EXPANDING HEMATOMA WAS OBSERVED. FURTHER MANIPULATION OF THE DEVICE WAS CEASED IMMEDIATELY. THE EXTERNAL PORTION OF THE WIRE WAS SECURED WITH HEMOSTATS TO PREVENT MIGRATION. HEMOSTASIS WAS MAINTAINED, AND THE INSERTION SITE WAS COVERED WITH A STERILE DRESSING AND A CHLORHEXIDINE GLUCONATE (CHG) IMPREGNATED PROTECTIVE DISK DRESSING. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO INTERVENTIONAL RADIOLOGY FOR REMOVAL OF THE RETAINED SWG SEGMENT. IT WAS ALSO REPORTED THAT A NEW ARTERIAL CATHETER WAS SUCCESSFULLY PLACED. IT WAS ALSO REPORTED THAT THE PATIENT SUBSEQUENTLY EXPIRED DUE TO SEPSIS ASSOCIATED WITH A PRE-EXISTING PERMANENT CATHETER. THE SEPSIS INFECTION WAS REPORTED TO HAVE BEEN PRESENT PRIOR TO THE REPORTED EVENT AND WAS THE REASON FOR THE PATIENT'S EMERGENCY DEPARTMENT ADMISSION.