Updated sections: g4, g7, h2, h3, h6, h10.Trackwise # (b)(4).The device was returned to the factory for evaluation on 12/27/2019.An investigation was conducted on 02/04/2020.A visual inspection was conducted.While it was reported that the failure occurred prior to the package being opened, signs of clinical use and slight evidence of blood was observed on the side of the loading device.The delivery device was returned partially inside the loading device with the white plunger not depressed and the blue slide lock not engaged.The delivery device was removed from the loading device.The seal and tension spring assembly remained inside the loading device.Based on the position of the seal and the white plunger, we can conclude that the seal was not loaded correctly.The seal and tension spring assembly was removed from the loading device.No visual defects were observed.The following measurements were taken; the inner delivery tube diameter was measured at.196 in.The outer diameter was measured at.220 in.The length of the delivery tube was measured at 2.49 in.The values recorded were within the tolerance specifications.Based upon the received condition of the device, the reported complaint ¿premature deployment¿ was not confirmed but was confirmed for the analyzed failure ¿fitting problem¿.
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