Description of Event or Problem · 0
IN A CLINICAL VT RESEARCH CASE WITH THE MEDTRONIC ECGI VEST, USING CARTO TO VERIFY INFO FROM VEST. WANTED TO MAP LV FIRST SO ATTEMPTED TRANSSEPTAL PUNCTURE AND FAILED, SO WENT WITH A RETROGRADE APPROACH VIA AORTA AND MAPPED WITH PENTARAY, BUT GOT A LOT OF ECTOPY SO CONTINUED TO MAP WITH SMARTTOUCH. THEN WANTED TO MAP RV SO WE WENT TO RA AND WHAT WE THOUGHT WAS INTO THE RV TO MAP WITH THE DECANAV. WE'D BEEN MAPPING FOR ABOUT 20 MINUTES AND THEN THE PATIENT'S BLOOD PRESSURE BEGAN TO SLOWLY DROP. WE DID AN ECHO AND SAW AN EFFUSION OF AROUND 1CM. WE PUT A CHEST DRAIN IN AND THE PATIENT WENT INTO VT WHICH DROPPED HIS BLOOD PRESSURE FURTHER. HE HAS AN ICD IN SITU AND WE SHOCKED HIM THROUGH THE DEVICE. WE THEN PUT THE PATIENT UNDER GENERAL ANESTHETIC AND REALIZED THAT WHAT WE THOUGHT WAS THE RV GEOMETRY WAS EPICARDIUM GEOMETRY. WHEN WE PUT UP THE GEOMETRY OF THE AORTA IT WAS CLEAR THAT THE FAILED TRANSSEPTAL PUNCTURE WAS ANTERIOR TO THE AORTA AND HAD PUNCTURED THROUGH TO THE EPICARDIUM. WE THEN HAD PUT THE DECANAV THROUGH THE HOLE LEFT BY THE TSP. THE EPICARDIUM MAP REVEALED A LARGE AREA OF SCAR, THE ENDOCARDIUM OF RV AND LV DID NOT REVEAL EXTENSIVE SCAR, SO THE CULPRIT LOCATION OF THE VT ORIGIN TURNED OUT TO BE EPICARDIALLY AROUND THE LV. IN TOTAL THE PATIENT HAD 2 SHOCKS THROUGH HIS ICD AND HAD A SMALL PERICARDIAL EFFUSION WITH A CHEST DRAIN PUT IN PLACE. THE ADVERSE EVENT WAS DUE TO THE FAILED TSP LOCATION, AND THE DOCTORS DO NOT BELIEVE THAT THE CATHETERS WERE INVOLVED IN CAUSING THE PROBLEM. PATIENT WAS STABLE UNDER GENERAL ANAESTHETIC AND HAD NOT AWOKEN AT TIME OF WRITING REPORT. WE HAD NOT DONE ANY ABLATION WHEN THE INCIDENT OCCURRED AND THE DOCTORS HAVE AGREED THAT THE CATHETERS WERE NOT TO BLAME. ADDITIONAL INFORMATION WAS RECEIVED ON 03/26/2018: PHYSICIAN'S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO THE FAILED TRANSSEPTAL PUNCTURE WITH THE ST. JUDE MEDICAL BRK TRANSSEPTAL NEEDLE. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).