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

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2026,"THE ANESTHESIOLOGY DEPARTMENT REPORTED THAT THE SPRING WIRE GUIDE (SWG) COULD NOT PASS THROUGH THE INTRODUCER NEEDLE DURING USE ON THE PATIENT. THE OPERATOR OBSERVED THAT THE SWG WAS KINKED." THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE". NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED BEYOND REMOVAL OF THE AFFECTED DEVICE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING REPLACEMENT WITH ANOTHER DEVICE.