(b)(4).Investigation/evaluation: a review of complain history, instructions for use, manufacturing instructions, quality control, specifications, trends and a dimensional verification and visual inspection of the returned device was conducted during the investigation.The chest drain catheter was returned for the investigation.The catheter appeared intact and showed no damage.The wire guide elongated at 11.5 cm from the proximal tip and stopped at 21.0 cm.It elongated again at 29.0 cm.The core wire was 67.0 cm from proximal end and was separated from the distal tip.The safety wire was severed in two pieces.It was 61.7 cm from the proximal end and 48.3 cm from the distal end.There is no evidence to suggest the product was not manufactured to current specifications.A definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
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