It is not known what caused the pericardial effusion.It is highly unlikely that the pericardial effusion was caused by the acqmap catheter.Specifically, as stated by the acutus account manager in the event description, the acqmap catheter used in the case was not returned for investigation; the catheter was disposed of by the medical facility staff.There were several procedure related opportunities that may have contributed to or caused the event.Although a single transseptal puncture was used to access the left atrium, the procedure itself is technically demanding and carries the risk of severe complications including pericardial effusion.The acutus account manager talked to the physician after the reported adverse event and no statement by physician indicating the acqmap catheter was connected to the event.Therefore, since it cannot be determined what if any the acutus system may have played role in this event although it is likely procedure-related, and we believe reporting this event conservatively based on the available information.
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