A review of the device history record, which includes verification of all steps in the manufacturing of the catheter revision kit, verification of sterilization, and packaging for subject catheter revision kit was performed.The review did not identify any non-conformances, issues or capas associated with catheter revision kit.Device was discarded and not returned for additional evaluation and investigation.Per the instructions for use of the device, catheter fracture is a known possible risk of use of the device.Physician did not know the cause of the fracture.Internal complaint number: complaint-(b)(4).
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