MAUDE Adverse Event Report: COOK INC UNIVERSA SOFT URETERAL STENT SET; FAD STENT, URETERAL

Model Number	G49974
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
Discoloration of the universa soft ureteral stent set was observed prior to insertion in the patient.This device was not used on the patient.No additional procedures were required due to this issue.No adverse consequences or adverse effects were caused to the patient.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a visual examination of the returned stent was conducted.A review of complaint history, the device history record, quality control data and specifications was also performed.One open package labeled rpn ush-626-r with label lot number 7348821 was received.The distal coil is discolored and continues down 1cm beyond the ink band.Then 7cm of stent body has no discoloration.Beyond this point discoloration resumed and extended for another 12.5cm, then ceased.The remaining 5.5cm and proximal coil had no discoloration.Discoloration could not be wiped off during examination.The device history record was reviewed and noted there were no non-conformances.A review of complaint history shows this complaint to be the only reported complaint associated with the complaint lot number.The supplier of the raw material tubing that is used in this product completed an investigation.A review of the lot records for the raw material and process for the tubing manufacture revealed no anomalies.It was identified that one of the raw materials used in the tubing to give it its radiopaque characteristic reacts to light by turning a yellowish/brownish color similar to what is observed in the photographs of the complaint product.As the tubing is only turning colors in the areas that are not covered by the label, it is likely that the parts are being stored in a manner that exposes them to light.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Based on the information from the supplier of the tubing used in the stent, light exposure during shipping or storage of the finished product could have contributed to this complaint.The stent pouch was likely removed from the outer protective carton box during storage and exposed to lighted conditions causing the stent material to discolor.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6913278
• Report Number: 1820334-2017-03428
• Device Sequence Number: 19128140
• Product Code: FAD
• UDI-Device Identifier: 10827002499741
• UDI-Public: (01)10827002499741(17)191011(10)7348821
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G49974
• Device Catalogue Number: USH-626-R
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 10/04/2017
• Supplement Report FDA Received Date: 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1