ACIST

Description of Event or Problem

DURING AN ANGIOGRAPHY FOR RIGHT AND LEFT HEART CATHETERIZATION WITH GRAFTS DUE TO CARDIOMYOPATHY (CM) AND CONSTRICTIVE PERICARDITIS (CP), AN AIR INJECTION OCCURRED. THE JR4 WAS UTILIZED TO PLACE A J-WIRE TO THE LEFT SUBCLAVIAN AND THEN EXCHANGED BACK FOR THE 6 FRENCH IMA GUIDE CATHETER. UNFORTUNATELY, THE IMA GUIDE CATHETER HAS SLIGHTLY DIFFERENT ANGULATION THAN THE DIAGNOSTIC CATHETER AND DID NOT SEAT THE IMA WELL. ULTIMATELY THIS WAS EXCHANGED FOR A 6 FRENCH, JR4 GUIDE CATHETER. THE JR4 WAS NOT SEEN WELL COAXIALLY BUT DID SEE BETTER THAN THE IMA CATHETER. A 0.014 INCH RUN-THROUGH GUIDEWIRE WAS INSERTED, AND WITH LITTLE DIFFICULTY, WAS ABLE TO BE PLACED IN THE IMA AND CAREFULLY DOWN THE INTERNAL MAMMARY ARTERY, CROSSED THE ANASTOMOTIC SITE, CROSSED THE DISTAL LESION INTO THE APICAL VESSEL FOR SUPPORT. VERY CAREFULLY A 1.5 X 12 MM TAKERU WAS PLACED THROUGH THE GRAFT AND INTO THE LESION. MULTIPLE HIGH-PRESSURE INFLATIONS WERE PERFORMED. THE BALLOON WAS REMOVED FROM THE BODY AND ANGIOGRAPHY WAS OBTAINED REVEALING IMPROVEMENT OF LESION. A 2.0 X 12 TAKERU WAS THEN PLACED VERY CAREFULLY THROUGH THE GRAFT AND ACROSS THE LESION. MULTIPLE BALLOON INFLATIONS WERE PERFORMED. THE BALLOON WAS REMOVED FROM THE BODY, AND ANGIOGRAPHY WAS OBTAINED REVEALING SIGNIFICANT IMPROVEMENT OF THE LESION. THERE WAS NO EVIDENCE OF DISSECTION OR PERFORATION. A 2.25 X 23 MM XIENCE DES WAS INSERTED CAREFULLY THROUGH THE GRAFT AND ACROSS THE LESION IN THE NATIVE LEFT ANTERIOR DESCENDING ARTERY (LAD). ONCE IN ADEQUATE POSITIONING, THE STENT WAS DEPLOYED TO NOMINAL PRESSURES. ADDITIONAL NOMINAL PRESSURE INFLATION WAS PERFORMED UTILIZING THE STENT BALLOON. THE STENT BALLOON WAS REMOVED FROM THE BODY, AND ANGIOGRAPHY WAS OBTAINED REVEALING EXCELLENT RESULTS. THERE WAS NO EVIDENCE OF DISSECTION OR PERFORATION. THERE WAS TIMI-3 FLOW. THE WIRE WAS REMOVED FROM THE BODY, AND PLANS WERE FOR COAXIAL IMAGES. IN WHAT WAS GOING TO BE THE FINAL INJECTION, A SINGLE, 7CC AIR BUBBLE WAS NOTED. FORTUNATELY, THIS PASSED THROUGH THE PATIENT'S SYSTEM WITHOUT ANY ILL EFFECT. INTRACORONARY NITROGLYCERIN WAS GIVEN AND OBTAINED IMAGES CONFIRMING CONTINUED TIMI-3 FLOW. THE CATHETER WAS REMOVED FROM THE BODY.

Additional Manufacturer Narrative

D4: ACIST SINGLE-USE MANIFOLD KIT, MODEL BT2000, LOT 05926B; AND ACIST ANGIOTOUCH HAND CONTROLLER KIT, MODEL AT-P54, LOT 06626A. THE ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CVI, SERIAL NUMBER (B)(6) HAS NOT YET BEEN RETURNED TO ACIST. THE CONSUMABLES USED DURING THE EVENT, ACIST SINGLE-USE MANIFOLD KIT, MODEL BT2000, LOT 05926B; AND ACIST ANGIOTOUCH HAND CONTROLLER KIT, MODEL AT-P54, LOT 06626A CONSUMABLE KITS USED DURING THE EVENT, WERE RETURNED TO ACIST FOR EVALUATION. FUNCTIONAL TESTING WAS COMPLETED ON THE CONSUMABLE KITS AND THE CONSUMABLE KITS PASSED THE TESTING. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION OF THE CONSUMABLES RELATED TO THE REPORTED EVENT. THE CINE-ANGIOGRAMS HAVE BEEN RETURNED, BUT NOT YET EVAULATED BY THE ACIST MEDICAL ADVISORY BOARD MEMBER. UPON COMPLETION OF THE INVESTIGATION, ACIST WILL SUBMIT THE FOLLOW-UP REPORT.