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It was reported a cardiac perforation and pericardial effusion occurred.The procedure was cancelled.During an atrial fibrillation (a fib) ablation procedure, a versacross access kit was selected for use.The physician was utilized radial intracardiac echocardiography (ice) and fluoroscopy to navigate transseptal puncture.Upon crossing, the physician received an unusual pressure waveform readouts not indicative of being in the left atrium.The physician proceeded to advance a non-boston scientific mapping catheter through the versacross sheath to check for signals indicating the location however the catheter had no signals once advanced out of the sheath.The physician noted the catheter appeared to be outside of the cardiac silhouette on fluoroscopy.The physician pulled the sheath back into the right atrium and performed a cti flutter ablation with a non-boston scientific radio frequency catheter in the right atrium.Effusion was checked post- procedure and was confirmed on ice.It was noted that the perforation occurred in the dome of the left atrium.The physician then performed a pericardiocentesis on the patient, and once complete the patient was taken to holding but the discharge status is unknown.The patient was taken to the or later that day due to the effusion.The device is not expected to be returned for analysis (disposed).The cti flutter ablation was performed post-unsuccessful transseptal, but the a fib portion of the procedure was cancelled.The physician delivered rf and crossed into a space which was not where he intended (based on subsequent pressure readings and fluoro/mapping images) thus the effusion and unsuccessful transseptal.He only attempted the single crossing.Post-case, the physician mentioned the anatomy was unusual.No malfunctioned noted with versacross devices.
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