ARROW PACING/PSI KIT: 5 FR/6 FR 2-L

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT, DURING PATIENT USE, FLUID BACKUP INTO THE CATH-GARD CONTAMINATION SHIELD WAS OBSERVED. THE CONNECTIONS WERE SUBSEQUENTLY ASSESSED. GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED DEVICE ISSUE AND TO ASSESS WHETHER ANY PATIENT HARM, INJURY, OR ADVERSE HEALTH CONSEQUENCES OCCURRED. A TOTAL OF THREE DOCUMENTED ATTEMPTS WERE MADE TO CONTACT THE USER FACILITY; HOWEVER, NO RESPONSE OR ADDITIONAL INFORMATION WAS RECEIVED.