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

Additional Manufacturer Narrative

(B)(4)

Description of Event or Problem

IT WAS REPORTED THAT A 22G ARROW ARTERIAL CATHETER WAS USED DURING AN ATTEMPTED LEFT RADIAL ARTERIAL LINE PLACEMENT UNDER ULTRASOUND GUIDANCE IN THE SURGICAL INTENSIVE CARE UNIT (SICU). BLOOD FLASHBACK WAS OBSERVED AND THE SPRING WIRE GUIDE (SWG) ADVANCED WITHOUT DIFFICULTY. HOWEVER, DURING REMOVAL OF THE SWG, THE CATHETER REPORTEDLY FRACTURED IN THE PATIENT'S WRIST. THE VISIBLE PORTION OF THE CATHETER WAS REMOVED BY THE USER; HOWEVER, IT REPORTEDLY BROKE INTO MULTIPLE PIECES DURING REMOVAL. NO ADDITIONAL FRAGMENTS COULD BE PALPATED, BUT IT COULD NOT BE CONFIRMED WHETHER THE CATHETER WAS COMPLETELY REMOVED. ADDITIONAL IMAGING WAS PLANNED TO EVALUATE FOR POSSIBLE RETAINED CATHETER FRAGMENT(S). NO FURTHER PATIENT OUTCOME INFORMATION WAS PROVIDED. GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE DEVICE, EVENT DETAILS, AND PATIENT OUTCOME. THREE DOCUMENTED ATTEMPTS WERE MADE TO CONTACT THE REPORTING FACILITY; HOWEVER, NO RESPONSE WAS RECEIVED. THEREFORE, THE ROOT CAUSE AND WHETHER ANY CATHETER MATERIAL REMAINED IN THE PATIENT COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY.