Pma/510(k) # k160229.(b)(4).Complaint device was not returned therefore a document based review will be performed.An image of the complaint device was shared which seems to indicate a kink distally.This is also detailed in the additional information.Prior to distribution, all echo-hd-22-ebus-p-c devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at (b)(4).A review of the manufacturing records for echo-hd-22-ebus-p-c of lot number c1599455 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1599455.The notes section of the instructions for use, which accompanies this device instructs the user to; "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".There is no evidence to suggest that the customer did not follow the instructions for use.The failure of needle kinked/bent was concluded from the available information.A definitive root cause could not be determined from the available information.A possible root cause could be attributed to excessive force as indicated in the complaint description causing the distal end of the needle to kink and issues with advancement.Complaint is confirmed based on the customer's testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
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