ACIST

Description of Event or Problem

DURING A FRACTIONAL FLOW RESERVE (FFR) PROCEDURE USING THE RXI SYSTEM AND NAVVUS II CATHETER, A PHYSICIAN NOTICED THE NAVVUS II CATHETER FRACTURED WITHIN THE GUIDING WIRE. USING A SNARE WIRE, THE PHYSICIAN WAS ABLE TO IMMEDIATELY RECOVER THE FRACTURED PIECE OF THE CATHETER THAT WAS FULLY CONTAINED WITHIN THE GUIDE CATHETER. THERE WAS NO INJURY TO THE PATIENT.

Additional Manufacturer Narrative

THE NAVVUS II CATHETER, LOT 0000305313, IS NOT AVAILABLE FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WILL BE PERFORMED FOR THE INVESTIGATION, UPON COMPLETION, A FOLLOW-UP REPORT WILL BE SUBMITTED TO THE FDA.

Additional Manufacturer Narrative

THE NAVVUS II CATHETER USED DURING THE EVENT WAS NOT EVALUATED AS IT HAD BEEN DISCARDED BY THE USER FACILITY AFTER THE EVENT. A REVIEW OF DEVICE HISTORY RECORD FOR LOT: 0000305313 WAS COMPLETED AND THERE WERE NO QUALITY ISSUES NOTED DURING THE MANUFACTURE OF THIS LOT. PER THE ACIST RXI / NAVVUS USER GUIDE, "ALWAYS ADVANCE OR WITHDRAW THE MICROCATHETER SLOWLY AND CAREFULLY. NEVER ADVANCE OR WITHDRAW THE MICROCATHETER AGAINST RESISTANCE UNTIL THE CAUSE OF THE RESISTANCE IS DETERMINED BY FLUOROSCOPY. MOVEMENT OF THE MICROCATHETER OR GUIDEWIRE AGAINST RESISTANCE MAY RESULT IN SEPARATION OF THE MICROCATHETER OR GUIDEWIRE TIP, DAMAGE TO THE MICROCATHETER, DISTAL EMBOLIZAION OF BLOOD CLOTS AND PLAQUE, OR VESSEL PERFORATION." THE CAUSE OF THE EVENT IS INCONCLUSIVE.