Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the sheath tubing was separated into 8 segments.Segments 1, 2, and 3 were connected by exposed coil.Segments 6, 7, and 8 were also connected by exposed coil.There were 4 compressions noted on segment 4; three of the compressions were 4 mm in length, and one compression was 3 mm in length.There was a 5 mm split on segment 5.Eight compressions, each 2 mm in length, were noted on segment 6, and six 2 mm compressions were noted on segment 8.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.
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