Description of Event or Problem · 1
THE BRIDGEPOINT MEDICAL CROSSBOSS CATHETER WAS USED DURING A PROCEDURE OF AN RCA WITH BOTH A PROXIMAL AND A DISTAL CTO LESION IN WHICH THE PT SUFFERED AN ARRHYTHMIC AND HEMODYNAMIC EVENT REQUIRING ACLS PROTOCOLS AND HYPOTHERMIA TREATMENT. THE EVENT WAS REPORTED AS FOLLOWS: THERE HAD BEEN DIFFICULTY WITH GUIDE CATHETER SUPPORT AND FINALLY THE PHYSICIAN WAS ABLE TO POSITION AN AL1 SHAPED GUIDE CATHETER INTO THE OSTIUM OF THE RCA. THE GUIDE CATHETER WAS DEEP SEATED INTO THE PROXIMAL RCA TO ENABLE GETTING PCI GEAR TO THE CTO LESIONS. THE CROSSBOSS CATHETER WAS INTRODUCED OVER A SHORT LENGTH GUIDEWIRE INTO THE RCA AND TRANSVERSED THROUGH BOTH CTO LESIONS VIA THE TRUE LUMEN PATHWAY TO THE DISTAL VESSEL. AT THIS TIME, THE DECISION WAS MADE TO EXCHANGE THE SHORT GUIDEWIRE FOR A LONG GUIDEWIRE TO MAKE CATHETER EXCHANGES WHEN THE PT SUFFERED AN EPISODE OF BRADYCARDIA. IT WAS NOTICED THAT THE GUIDE CATHETER HAD DEEP SEATED FURTHER INTO THE RCA AND WAS ACROSS THE CONUS BRANCH. THE GUIDE CATHETER WAS RETRACTED BACK TO THE OSTIUM OF THE RCA AND THE PT STABILIZED BACK TO A NORMAL RHYTHM. THE LONG GUIDEWIRE WAS THEN INTRODUCED INTO THE CROSSBOSS CATHETER AND POSITIONED IN THE DISTAL VESSEL BUT PRIOR TO THE CROSSBOSS BEING REMOVED FROM THE VESSEL, THE PT WENT ASYSTOLE AND THE PT'S B/P DROPPED SIGNIFICANTLY. THE GUIDE CATHETER WAS WITHDRAWN FROM THE RCA INTO THE AORTA. ACLS PROTOCOLS WERE INITIATED, WHICH INCLUDED MEDICATION DRIPS TO ELEVATE THE B/P, INTUBATION, AND CARDIOVERSION. AN ECHOCARDIOGRAM WAS DONE TO CHECK FOR A PERFORATION AND SHOWED NO EXTRAVASATIONS. PT CONTINUED TO BE HEMODYNAMICALLY COMPROMISED AND A BALLOON PUMP WAS INTRODUCED WITHOUT SIGNIFICANT EFFECT. A LEFT VENTRICLE ASSIST DEVICE WAS INTRODUCED AND WAS FOUND NOT TO BE FUNCTIONING; THIS WAS REMOVED AND REPLACED WITH ANOTHER LV ASSIST DEVICE, WHICH FUNCTIONED AS INTENDED. PT STABILIZED SIGNIFICANTLY WITH THE LV ASSIST, A SECOND ECHOCARDIOGRAM WAS DONE, WHICH AGAIN WAS NEGATIVE FOR EXTRAVASATIONS. THE CROSSBOSS CATHETER AND GUIDEWIRE WAS REMOVED AT THIS TIME AND AN ANGIOGRAM WAS PERFORMED ON BOTH THE LEFT AND RIGHT CORONARY TREES. THE LEFT CORONARY TREE WAS UNCHANGED FROM THE BEGINNING OF THE PROCEDURE AND THE RIGHT CORONARY TREE NOW HAD AN OPEN, BUT DIFFUSELY DISEASED LUMEN. BOTH GUIDE CATHETERS WERE REMOVED AFTER THE ANGIOGRAM. THE DECISION WAS MADE AT THIS TIME TO PUT THE PT INTO HYPOTHERMIA TO ASSIST THE PT'S BODY IN RECOVERY FROM THE EVENT. THE PT WAS THEN TRANSFERRED TO ICU. ONE AND A HALF HOURS AFTER THE PROCEDURE, DR (B)(6) INFORMED (B)(4), BRIDGEPOINT MEDICAL CLINICAL SPECIALIST THAT THE PT WAS STABLE AND THAT ALL ACLS PROTOCOL MEDICATION DRIPS HAD BEEN DISCONTINUED. THE PT WAS TO REMAIN IN A HYPOTHERMIC STATE WITH THE LV ASSIST DEVICE OVERNIGHT, BUT FELT THAT BOTH WOULD BE DISCONTINUED ON (B)(6) 2012 AM. DR (B)(6) FELT THAT THE PT HAD SUFFERED A RIGHT VENTRICULAR INFARCT DURING THE PROCEDURE. DR (B)(6) ALSO STATED THAT HE WOULD CONTACT MR (B)(4) IF THERE WAS ANY CHANGE IN THE PT'S CONDITION AND TREATMENT FROM WHAT WAS PLANNED.