It was reported a patient underwent a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a smartablate¿ system irrigation pump (us) and the patient experienced an air embolism and medical intervention was required.It was reported that while doing the pulmonary vein isolation and toward the end of the procedure, the physician noticed bubbles inside the aorta.They reported that the patient's blood pressure dropped and heart rate slowed.The bubbles were confirmed with intracardiac echocardiography (ice).The physician performed heart cath maneuvers to determine where the bubbles originated from.The physician was unable to determine where the bubbles originated from during the procedure.The procedure was aborted.They were in the testing phase and that the therapeutic portion of the procedure was completed.The patient woke up, was breathing fine, and passed tests from the certified registered nurse anesthetist (crna) and nurses.The patient was sent to the emergency department to be evaluated per protocol.The patient was reported to be in stable condition.Post-procedure the physician determined that the bubbles had come from the pressure bag that was connected to the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.Additional information received indicated they performed a test after the case with the pump and bubble sensor and the equipment worked as intended.This adverse event was discovered during use of biosense webster products.Physician¿s opinion on the cause of this adverse event is that it was procedure related.The physician believes air got into the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.He speculated the most likely cause being from when he performed a catheter exchange.Intervention provided was that a heart cath was performed.The patient¿s outcome from the adverse event was reported as fully recovered (no residual effects).Patient required extended hospitalization because of the adverse event as they believe it is hospital protocol for the patient to remain overnight given an event occurring.Patient¿s medical history included an abg was performed (the results were all good).The patient did not exhibit any neurological symptoms since the procedure was completed.The patient was released from the hospital june 17, the day after the procedure.
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