MAUDE Adverse Event Report: COOK INCORPORATED COOK SOFT STENTS; STENT, URETERAL

Model Number G23384

Device Problems Crack (1135); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/12/2022

Event Type  Injury  

Event Description

Two stents placed, both fragmented.Of note: stent fragments show many fissures and cracks all along the length of the stent and around the drainage holes upon visual inspection.Fda safety report id# (b)(4).

• Brand Name: COOK SOFT STENTS
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): COOK INCORPORATED
• MDR Report Key: 15138176
• MDR Text Key: 297065014
• Report Number: MW5111196
• Device Sequence Number: 2
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/28/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: G23384
• Device Catalogue Number: G23384
• Device Lot Number: 9612255
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR
• Patient Sex: Male
• Patient Weight: 18 KG
• Patient Ethnicity: Non Hispanic