Following a radio frequency accessory pathway ablation procedure, a cardiac effusion occurred during insertion of the introducer on the left side of the heart.During the procedure, difficulty was noted inserting the sheath on the left side.However, the procedure went well with transesophageal ultrasound.A few hours post procedure, the patient experienced pain, weakness and a drop in blood pressure.An ultrasound was then performed which revealed a pericardial effusion.A pericardiocentesis was performed and a drain was placed to stabilize the patient.The drain was removed the following day.There were no performances issues with abbott devices.
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The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the effusion remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.
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