The international customer reported that, when the operator advanced the ultrathane mac-loc locking loop biliary drainage catheter over the wire guide to the lesion position, the bile would not flow out even after the wire guide and inner core were removed.The operator reported that the reason for the lack of flow was some type of obstruction.No adverse events were reported as a result of the product issue, and no additional procedures were necessitated.The product is reportedly available for return; however, as of the date of this report, no product has yet been received for evaluation.
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Additional information: device evaluated by mfr.Corrected information: foreign, user facility, distributor, company representative.Investigation - evaluation: a review of dimensional verification, functional testing, complaint history, device history record, documentation, drawings, instructions for use (ifu), manufacturing instructions,quality control data, and visual inspection of the returned device was conducted during the investigation.One catheter was returned with the metal stiffener inserted within the lumen of the catheter.The stiffener was removed, and water was easily flushed through the lumen of the catheter.The failure was unable to be duplicated.It is possible that the drain blocked, but the blockage removed when the stiffener was inserted prior to return.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.Based on the provided information, inspection of returned product, and the results of our investigation, a definitive root cause cannot determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.
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