ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 25 CM

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DURING DEVICE INSERTION, THE PROCEDURE INITIALLY PROGRESSED WITHOUT ISSUE. HOWEVER, UPON REMOVAL OF THE SPRING WIRE GUIDE (SWG) FROM THE CATHETER, WHICH WAS ACCOMPLISHED WITHOUT RESISTANCE OR DIFFICULTY, THE SWG WAS OBSERVED TO BE UNRAVELED. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER DEVICE, WITH NO ADDITIONAL MEDICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT SUBSEQUENTLY EXPIRED; HOWEVER, THE EVENT WAS DETERMINED NOT TO HAVE CONTRIBUTED TO THE PATIENT'S DEATH.