(b)(4).Investigation/evaluation: during the course of the investigation, a review of the complaint history, quality control, device history record, manufacturing instructions, and documentation of the product was conducted.Images provided confirmed the introducer sheath hub detachment.The user stated that two devices from different lot numbers had the same issue, which could indicate that the user might have used excessive force.However, without additional information it was not possible to investigate the root cause any further.It was noted that the event did not harm the patient and that the procedure was completed successfully using a new device.To address the issue of excessive force, the ifu warns that excessive force should not be exerted.There was not any evidence found to suggest that this device was not manufactured according to specifications.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.
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