The device was returned to the manufacturer on 14 sept 2021.The device investigation was completed on 16 sept 2021.The device was returned and evaluated by a cross functional team.Wrinkles were seen on the device''s outer jacket, 45.75in from the distal tip.Dead fibers and a breach to the outer jacket were seen in the area of the wrinkles.8-9 dead fibers were seen at both the distal tip and the proximal coupler.Likely, the device''s outer jacket became caught on an unknown structure, causing the wrinkles in and a breach to the outer jacket.This failure has been determined to be use related.
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