ACIST

Description of Event or Problem

DURING A FRACTIONAL FLOW RESERVE (FFR) PROCEDURE USING THE ACIST RAPID EXCHANGE FFR SYSTEM, MODEL RXI, AND NAVVUS CATHETER, A USER FACILITY REPORTED THAT THEY WERE UNABLE TO EQUALIZE THE SYSTEM DUE TO RECEIVING AN ERROR FOR THE CATHETER PRESSURE SENSOR. WHILE TRYING TO GET THE SYSTEM TO EQUALIZE, THE CATHETER WAS LEFT IN THE PATIENT. A BLOOD CLOT FORMED AROUND THE SIGHT WHERE THE CATHETER WAS LOCATED. THE PATIENT WAS ADMINISTERED MORPHINE FOR PAIN.

Additional Manufacturer Narrative

CATHETER LOT NUMBERS WERE REQUESTED BUT NOT PROVIDED. THE RXI SYSTEM, SERIAL NUMBER (B)(4), WAS REQUESTED TO BE RETURNED TO ACIST FOR INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA.

Additional Manufacturer Narrative

THE RXI SYSTEM AND NAVVUS CATHETERS USED DURING THE EVENT WERE REQUESTED BY ACIST TO BE RETURNED FOR INVESTIGATION. THE USER FACILITY ELECTED NOT TO SEND THE RXI SYSTEM TO ACIST FOR INVESTIGATION; THEY ATTRIBUTED THE EVENT TO USER ERROR. THE NAVVUS CATHETERS WERE DISCARDED BY THE USER FACILITY AND THE LOT NUMBERS WERE NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE ACIST RXI CONSOLE, SERIAL NUMBER (B)(6).WAS PERFORMED ON JULY 1, 2022. THE REVIEW FOUND NO QUALITY ISSUES DURING THE MANUFACTURE OF THE DEVICE RELATED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE HAVE BEEN REVIEWED AND NO INADEQUACIES WERE IDENTIFIED REGARDING WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE USE OF THE DEVICE.