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

Catalog Number	025807-S1
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2015
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.
Event or Problem Description
The complainant reported that the bander ureteral diversion stent had been placed for ileum conduit for about 3 weeks.Anastomotic stenosis was observed.The user inserted the supplied wire guide into the stent to exchange for new one, but the wire guide got stuck in the stent.It was further noted that the coils on the safety wire were stretched.The user then inserted another manufacturer's wire guide along the stent and removed the stent and the wire guide together from the patient.The new bander ureteral diversion stent was inserted over the other manufacturer's wire guide and placed successfully.There were no reported serious injuries to the patient as a result of the product problem.

• 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: 7421125
• Report Number: 1820334-2018-01089
• Device Sequence Number: 19218390
• Product Code: GBL
• UDI-Device Identifier: 00827002148239
• UDI-Public: (01)00827002148239(17)171001(10)5323536
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/11/2018

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: 025807-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: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1