One 4mm tip, large curl, safire ablation catheter was received for evaluation.The catheter successfully attached to a test box with no anomalies noted.Electrodes 1-4 displayed acceptable resistance values ranging from 1.3 ohms to 1.9 ohms while the device was undeflected, deflected, and manipulated, with no open or short circuits detected.The resistance value between pins 11 and 12 read as 152.2 ohms and the value between 12 and 13 read as 24.3 ohms while undeflected, deflected, and during manipulation, which met specifications.The temperature response was checked at three settings: 25.0°c, 37.0°c and 90.0°c using a calibrated system.The catheter displayed the following temperature readings: 25.3°c, 36.9°c, and 93.0°c.The temperature response of the thermocouple was within specification.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported issue remains unknown.
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