Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the catheter was separated into two sections.The catheter appeared elongated.The proximal section was measured to be 122.8 cm in length, and the distal section was measured to be 57.5 cm in length.The total length was measured to be 180.3 cm, which is outside the upper limit specification for length.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.It is likely, however, that patient condition and user technique are related to the event.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
|