MAUDE Adverse Event Report: COOK INC BANDER URETERAL DIVERSION STENT SET; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Catalog Number	025806-S1
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.Blank fields on this form indicate the information is unknown or unavailable.
Event or Problem Description
It was reported that when stent exchange for ureterocutaneous fistula was performed, there was an obstruction in the stent lumen.It was further noted that a foreign substance was observed inside the catheter.The user replaced it with another bander ureteral diversion stent and completed the procedure.The patient did not experience any adverse effects due to this occurrence.

• Brand Name: BANDER URETERAL DIVERSION STENT SET
• Common Device Name: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7411525
• Report Number: 1820334-2018-01054
• Device Sequence Number: 70394
• Product Code: GBL
• UDI-Device Identifier: 00827002168176
• UDI-Public: (01)00827002168176(17)190427(10)6921868
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2018

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 Catalogue Number: 025806-S1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1