Description of Event or Problem · 0
(CSI) CARDIOVASCULAR SYSTEMS INC. ATHERECTOMY DEVICE CAUSING PERFORATION OF THE CORONARY ARTERY AND SUBSEQUENTLY DEATH THE CARDIOVASCULAR SYSTEMS, INC. (CSI) DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS). I HAVE BEEN THE CATH LAB DIRECTOR AT (B)(6) HOSPITAL IN (B)(6) TWICE . I AM A BUSY INTERVENTIONAL CARDIOLOGIST. I HAVE BEEN BOARD-CERTIFIED IN CARDIOLOGY FOR 20 YEARS. THIS CASE I AM REPORTING HAPPENED WITH MY PARTNER WHERE THE CSI ATHERECTOMY CATHETER WAS USED APPROPRIATELY BY MY PARTNER WITH THE SUPPORT OF THE COMPANY REPRESENTATIVE. THE DEVICE CREATED A MASSIVE PERFORATION OF THE RIGHT CORONARY ARTERY THAT WAS UNSALVAGABLE RESULTING IN PATIENT DEATH. OVER THE LAST 2 YEARS, I HAVE SEEN IN SEVERAL HOSPITALS I GO TO, 3 DEATHS RELATED TO THE SAME DEVICE BY 3 OTHER OPERATORS. THE STANDARD OF CARE HAS BEEN ROTATIONAL ATHERECTOMY FOR DECADES WHICH IS SAFER THAN THIS PRETTY AGGRESSIVE DEVICE. EVERY CONFERENCE I GO TO AND EVERY INTERVENTIONALIST I HAVE MET OVER THE YEARS IN MAJOR ACADEMIC HOSPITALS SHOW OR MENTION A CASE OF MASSIVE PERFORATION. EVEN IN THE BOARD EXAM, IT WAS HINTED AT THAT. I BELIEVE THIS IS A POTENTIALLY DANGEROUS DEVICE DESPITE THE COMPANY TRYING TO TALK DOWN THE SERIOUS ORBITAL DAMAGE TO THE BLOOD VESSEL. THERE ARE SAFER OPTIONS NOWADAYS WITH SHOCKWAVE LITHOTRIPSY OR EVEN ROTATIONAL ATHERECTOMY . IF THERE IS NO WAY TO WITHDRAW THIS DEVICE FROM BEING USED IN THE CORONARY ARTERIES IN THE MARKET - I SUGGEST MAKING IT VERY DIFFICULT TO USE IT EXCEPT IN OPERATORS WHO DO 20 OR MORE ROTATIONAL ATHERECTOMIES A YEAR YES, THE 3-4 OPERATORS WHO HAD SOME DEATHS WITH THIS DEVICE USE IT ONLY VERY FEW TIMES A YEAR AND THE INDUSTRY COMPANY REPRESENTATIVES TEND TO PUSH MORE DOCTORS TO DO IT AND CLAIM IT TO BE A SAFER DEVICE.