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It has been reported that a versacross connect access solution kit was selected for use for a left atrial appendage closure procedure indicated for a case of nonvalvular atrial fibrillation (nvaf).A perforation, pericardial effusion and cardiac tamponade occurred; procedure cancelled.During the procedure, the physician mentioned that the patient had a lipomatous septum with limited transseptal crossing options.The versacross devices were used for transseptal.The location of the crossing was mid-mid and the wire/sheath crossed over into the left atrium with no complications.Shortly after, it was noticed that there was an increasing buildup of fluid in the transverse sinus.Thus, it was decided to view the pericardium with a abbott viewflex ice catheter, which is when they saw a large effusion and tamponade.Pericardiocentesis and an autotransfusion were performed, the patient became hemodynamically unstable, requiring intubation.The pericardiocentesis was said to be successful, although the bleeding continued, and the effusion did not appear to be decreasing on ice.A cardiothoracic (ct) surgery was then requested where a sternotomy was performed, and the source of the bleeding was found in the apex of the left atrial appendage (laa).Thus, the laa was ligated/excised, and the patient was sent to the intensive care unit (icu) for monitoring, procedure cancelled.Product is not expected to return for analysis (disposed).Prior to the procedure, a trivia-small effusion was noted, as well as fluid noted in the transverse sinus.Although, the initial effusion was in the right ventricle (rv), whereas the effusion that occurred during the procedure was in the left ventricle (lv) and noticeably larger.The patient was under conscious sedation during the procedure.The patient was not on warfarin or antiplatelet drugs at the time of the procedure.In the physician's opinion, the versacross rf wire perforated the laa.It has been further mentioned that 2-3 attempts were required to track up/drop down to the septum.It was also noted along with the use of a fluoroscopy to track the versacross rf wire up in front of the was sheath, since the wire kept getting looped around the pacemaker leads on the right side of the heart.It was mentioned that the versacross rf wire was advanced too far during transseptal.This time, the physician stated that the sheath was advanced with the versacross rf wire further than they would normally have, and due to the final position of the wire was the reason the effusion happened most likely.The patient was extubated and hemodynamically stable in the icu on the next day.
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