Related manufacturing reference: 3005334138-2019-00538, 2030404-2019-00101.Following an atrial fibrillation ablation procedure a transient ischemic attack occurred.During the procedure the patient was anticoagulated, the act was above 300, and a transesophageal echo was done prior to the procedure to rule out thrombosis.While in post-op unit the patient experienced mild confusion and slight weakness that resolved after a few minutes.There were no performance issues with any abbott device.
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The results of the investigation are inconclusive since the device was not returned for analysis; however, the log files from the tactisys quartz system were returned.The log file analysis concluded that the tacticath catheter performed as intended.The optical fibers met specifications, the recorded temperatures indicated cooling during rf ablation, and contact force measurements were displayed throughout the duration of the log files.Force measurements were recorded during ablation that exceeded the recommended values in the tacticath contact force ablation catheter, sensor enabled instructions for use (ifu); however, due to unknown procedural conditions we are unable to conclusively determine the cause of the reported event.The cause of the reported transient ischemic attack remains unknown.
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