Description of Event or Problem · 1
AS COMMUNICATED TO A RADI MEDICAL SYSTEM, INC. EMPLOYEE IN EARLY 2008, IN 2007 A MALE PATIENT ARRIVED IN A CARDIAC CATHETERIZATION LABORATORY COMPLAINING OF INTERMITTENT CHEST PAIN. CK ENZYMES WERE POSITIVE INDICATING SOME MYOCARDIAL DAMAGE. USING THE FOLLOWING PROCEDURE, THE PHYSICIAN PERFORMED A ROUTINE ANGIOGRAM AND DETERMINED THAT A PORTION OF THE LEFT ANTERIOR DESCENDING ARTERY SUGGESTED SOME CORONARY ARTERY DISEASE WHICH REQUIRED FURTHER INVESTIGATION. THE PROCEDURE COMMENCED ROUTINELY WITH AN INTRODUCER NEEDLE BEING INSERTED INTO THE FEMORAL ARTERY. AN INTRODUCER WIRE WAS INSERTED THROUGH THE NEEDLE INTO THE FEMORAL ARTERY. THE NEEDLE WAS THEN REMOVED AFTER WHICH AN INTRODUCER SHEATH WAS INSERTED OVER THE INTRODUCER WIRE. THE INTRODUCER WIRE WAS THEN REMOVED, AND A 0.035" DIAGNOSTIC GUIDEWIRE WAS INSERTED THROUGH THE SHEATH AND ADVANCED THROUGH THE FEMORAL AND ILIAC ARTERIES TERMINATING IN THE ARCH OF THE AORTA. AN ANGIOGRAPHIC CATHETER WAS ADVANCED OVER THIS WIRE TERMINATING IN THE LEFT MAIN CORONARY ARTERY. THE GUIDEWIRE WAS THEN REMOVED. A ROUTINE ANGIOGRAM WAS PERFORMED. THE ANGIOGRAPHIC CATHETER WAS REMOVED AND AN INTERVENTIONAL GUIDING CATHETER WAS INSERTED. AN INTERVENTIONAL GUIDEWIRE (PRESSUREWIRE) WAS ADVANCED THROUGH THE GUIDING CATHETER INTO THE LEFT MAIN CORONARY ARTERY AND INTO THE LEFT ANTERIOR DESCENDING ARTERY. ACCORDING TO THE PHYSICIAN, ALL OF THE FOREGOING DEVICES PERFORMED AS INTENDED. AN INFUSION PUMP WAS TURNED ON TO ADMINISTER ADENOSINE AT THE RATE OF 140 UG/KG/MIN. SHORTLY FOLLOWING ADENOSINE ADMINISTRATION, THE PATIENT WENT INTO CARDIAC ARREST AND WAS UNABLE TO BE REVISED. THE PATIENT EXPIRED IN THE CATHETERIZATION LABORATORY. DOSE OR AMOUNT: 140UG/KG/MIN. FREQUENCY: MIN, ROUTE: IV. DATE OF USE: NOVEMBER 2007, DIAGNOSIS OR REASON FOR USE: CONV. TO SINUS RHYTHM OF PSVT.