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

Model Number	N/A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported the ureteral stent product is too soft and slips off too easily.The reporter stated, ¿the life of this device is six months but in reality it must be replaced in the patient within three months, the patient also finds it difficult to leave in place." as stated in the complaint form from the reporter "product is too soft, you can not change it after 6 months (as stated in the data sheet) for these reasons it is necessary to repeat the stent replacement procedure.¿ according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of complaint history, device history review, quality control documentation and specification was conducted during the investigation.The complaint device was not returned therefore, device failure analysis and physical examination of the device used in this case could not be performed.There is no indication that a design or process related failure mode contributed to this event.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.In addition, review of device history record did not observe any non-conformances that may have contributed to this incident.Based on the information provided, the actual root cause is unknown and no conclusion can be drawn.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.Per the risk assessment no further action is required.

• 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: 6185070
• Report Number: 1820334-2016-01508
• Device Sequence Number: 13695775
• 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: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2017

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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2016
• Supplement Report FDA Received Date: 06/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1