MAUDE Adverse Event Report: COOK INC BANDER URETERAL DIVERSION STENT SET; FAD STENT, URETERAL

Model Number	N/A
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported the ureteral stent product ¿clogs immediately.¿ the reporter stated ¿stent should be replaced latest after four months because clog immediately.¿ the patient required an additional procedure due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the bander ureteral diversion stent set was not returned for an evaluation; therefore, a physical investigation could not be performed.The complaint report that the stent clogged immediately was unable to be confirmed.Based on the information provided, a definitive root cause cannot be determined or established at this time.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.A review of the device history record indicated that there were no non-conformances for this lot number.Additionally, a review of complaint history revealed this complaint to be one of two complaints with this lot number 7021020.The other complaint was reported by the same customer referencing the same device with a defect of ¿too soft, slips off too easily.¿ based on the quality engineering risk assessment; no further action is required.Cook medical has notified the appropriate personnel and the will continue to monitor the complaints database for similar complaints.

• Brand Name: BANDER URETERAL DIVERSION STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6181701
• Report Number: 1820334-2016-01509
• Device Sequence Number: 10795893
• Product Code: FAD
• UDI-Device Identifier: 00827002180703
• UDI-Public: (01)00827002180703(17)190603(10)7021020
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 025227-OE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2016
• Supplement Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 12/16/2016
• Supplement Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1