ARROW RA CATH SET: 20 GA X 1 1/2IN

Description of Event or Problem

IT WAS REPORTED THAT DURING THE INITIAL INSERTION OF AN ARTERIAL CATHETER UNDER ULTRASOUND GUIDANCE IN THE RADIAL ARTERY, THE SPRING WIRE GUIDE (SWG) WAS OBSERVED TO BE UNCOILED UPON REMOVAL FROM THE CATHETER. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE EVENT. THE PATIENT'S CONDITION WAS REPORTED AS UNCHANGED ("STATUS QUO"). THE AFFECTED DEVICE WAS REMOVED AND REPLACED WITH A NEW DEVICE, AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. IT WAS FURTHER REPORTED THAT THE ARTERY DID NOT CONTAIN SCAR TISSUE, PLAQUE, OR OTHER RIGID ANATOMICAL STRUCTURES, SUCH AS BONE OR MUSCLE MASS, THAT COULD HAVE INTERFERED WITH ARTERIAL PLACEMENT OR CONTRIBUTED TO THE REPORTED DEVICE ISSUE.

Additional Manufacturer Narrative

QN#(b)(4).