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

Additional Manufacturer Narrative

(B)(4)

Description of Event or Problem

IT WAS REPORTED THAT "THE GUIDEWIRE (LOOSE) UNRAVELED." 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 FOLLOWING REPLACEMENT WITH ANOTHER DEVICE. GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED DEVICE; HOWEVER, NO RESPONSE OR ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY.