Description of Event or Problem · 0
I WENT TO (B)(6) HOSPITAL (B)(6) FOR A VENOGRAM WITH DR. (B)(6) AND DR. (B)(6) ON (B)(6) 2026 DUE TO SEVERE SWELLING OF MY RIGHT CALF AND WOUNDS THAT WOULD NOT HEAL ON IT THAT KEPT ON GETTING INFECTED. DURING THE SURGERY, A PIECE OF THE MINI STICK MAX COAXIAL MICROINTRODUCER KIT BROKE OFF. THE PRODUCT WAS MANUFACTURED BY ANGIO DYNAMICS, 26 FOREST STREET, MARLBOROUGH, MA 01752: PRODUCT NUMBER H965457530, LOT# 5860435. THE PIECE THAT BROKE OFF DURING THE INSTALLATION OF STENTS INSERTED THROUGH THE NECK INTO MY LOWER BACK WHERE MY VEINS WERE VERY NARROW WAS APPROXIMATELY 2 INCHES LONG BY APPROXIMATELY 1 MILLIMETER IN DIAMETER. THE SURGEONS TRIED TO LOCATE THE PIECE DURING THE SURGERY BUT WERE UNABLE TO FIND IT. AFTER SURGERY, MY WIFE AND SON WERE TOLD BY DR. (B)(6) THAT THE PIECE WOULD LIKELY ADHERE TO THE WALL OF A VEIN. DUE TO THIS COMPLICATION, THE SURGEONS DECIDED TO ADMIT ME TO THE HOSPITAL FOR OBSERVATION. DURING THE NIGHT, MY HEART STARTED BEATING IRREGULARLY WHICH CONTINUED INTO THE MORNING. ON TUESDAY, (B)(6) 2026, I WAS PUT ON AMIODARONE AND METOPROLOL SUCCINATE TO CONTROL MY HEARTBEAT. THEY THEN DID AN ECHOCARDIOGRAM AND A CT SCAN TO DETERMINE MY HEART RHYTHM AND TO ASCERTAIN THE EXACT LOCATION OF THE PIECE THAT BROKE OFF. THEY LOCATED IT IN THE RIGHT VENTRICLE OF MY HEART, AND THEY KEPT ME IN THE HOSPITAL A SECOND NIGHT FOR MORE OBSERVATION. THE PROFESSIONAL OPINION OF THE SURGEONS IS THAT THE MATERIAL WAS DEFECTIVE, WHICH LED TO ITS SEPARATION. UPON RELEASE, I WAS PUT ON A HEART MONITOR FOR TWO WEEKS AND THE MEDICATION CONTINUED. I AM STILL UNDER THE CARDIOLOGIST'S CARE AND WILL BE GOING FOR FURTHER TESTING SUCH AS ANOTHER CT SCAN AND/OR ECHOCARDIOGRAM TO SEE IF THE PIECE IN MY HEART HAS MOVED. I WAS TOLD THAT IF THE RESULTS FROM THE FIRST HEART MONITOR ARE OKAY, I WILL BE TAKEN OFF THE MEDICATION AND WILL NEED TO WEAR ANOTHER HEART MONITOR TO DETERMINE HOW MV HEART REACTS WITHOUT THE MEDICATION.