MAUDE Adverse Event Report: COOK INCORPORATED BANDER URETERAL DIVERSION STENT SET GTIN; CATHETER, NEPHROSTOMY

Model Number 025237

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/22/2021

Event Type  malfunction  

Event Description

Patient had bilateral ureteral stents placed on (b)(6) 2021 during a surgical procedure.The stents were removed on post op day 11.Upon removal one of the ureteral stents broke.The broken piece of the stent was able to be removed by manual manipulation through the ostomy.The stent was a cooks medical bander ureteral diversion stent.The broken portion of the stent has been retained.Fda safety report id# (b)(4).

• Brand Name: BANDER URETERAL DIVERSION STENT SET GTIN
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INCORPORATED
• MDR Report Key: 12975896
• MDR Text Key: 282126443
• Report Number: MW5105955
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/07/2021

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
• Device Operator: Health Professional
• Device Model Number: 025237
• Device Catalogue Number: G16994
• Device Lot Number: 13879874
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Male