A report was received indicating that cardiac tamponade occurred in pt undergoing a cardiac ablation procedure.This report is being submitted by baylis medical as the nrg transseptal needle was one of the devices used during the procedure.During the procedure, the nrg transseptal needle was used with an sl0 introducer.The slo introducer was not supplied by baylis medical.Prior to rf energy delivery, while the physician was manipulating the devices to try to locate the desired puncture site, the assembly of transseptal devices inadvertently crossed at an unexpected site.No rf energy was applied.The physician confirmed the position of the devices in the left atrium by contrast dye injection, and continued to advance the sheath.At this point, the pt's blood pressure was observed to decrease.Pericardial effusion was then confirmed by echocardiogram.The physician indicated that a cardiac tamponade had occurred and pericardiocentesis was performed.The effusion site could not be identified.The pt prognosis was reported to be well after surgery.There is no evidence to suggest that the nrg needle caused or contributed to the unexpected perforation in the pt, which resulted in the cardiac tamponade.However, as nrg transseptal needle was one of various transseptal devices used in the procedure, baylis medical has decided to submit this report.
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