A review of the device history record, which includes verification of all steps in the manufacturing of the catheter kit and sub assembly, verification of all final testing performed by/on the catheter kit and sub assembly, verification of sterilization, and packaging for subject catheter kit and sub assembly was performed.The review did not identify any non-conformances, issues or capas associated with catheter kit and sub assembly function.Device was not returned for additional evaluation and investigation.Representative reported that the cause of the catheter coiling was unknown.Per the instructions for use of the device, catheter coiling is a known possible risk of use of the device.Internal complaint number: (b)(4).
|