Investigation ¿ evaluation: a review of the complaint history, device history record, drawing, manufacturing instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of 5 mm of scrape type damage on the distal end of the outer layer of tubing.In the 5 mm damaged section, 1 mm of the outer layer of tubing was separated longitudinally.The inner sheath liner was intact, and no coil was exposed.The distal edge of the sheath was damaged, and slightly stretched at the transition.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.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.
|