Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.It was reported that there was a "crease" on the side of a "drainage hole" of a stent from a universa soft ureteral stent set (part number ush-526).The alleged defect was identified prior to the procedure and a new stent set was used instead.Following additional inquiries it was reported the tether disconnected from the stent when the physician took the stent out of the package.The crease was then identified.A visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, the instructions for use, specifications, and quality control data.The complainant returned one open package containing a universa soft stent for investigation.Visual examination confirmed stent and positioner only were returned in prior to use condition.Stent and positioner received.No damage observed on the positioner.The tether was not returned with the stent.A tear is confirmed on the stent¿s proximal coil.Closer examination revealed the tear originated at the last side port measuring 5mm long.No other damage found on the stent.Stent was damaged during tether removal.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: "the tether should be removed if the stent is to remain indwelling longer than 14 days." the returned stent was inspected, the tether was not returned with the stent.A 5mm tear on the stent¿s proximal coil that originated at the last sideport on the proximal coil was observed.The last sideport on the proximal coil is also where the tether would originally have been attached to the stent.Based on the evidence presented by the sample, this event has been contributed to rigorous handling of the device in a clinical setting.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.
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