SOF-FLEX MULTI-LENGTH URETERAL STENT SET
Received Jul 27, 2026 · Event occurred Jun 23, 2026
Report 1820334-2026-00750 · MDR key 50035829
Device
Product problems
- Break
Patient
Female
- Foreign Body In Patient
Narrative
Description of Event or Problem
It was reported, a stent from a Sof-Flex Multi-Length Ureteral Stent Set was implanted into a child (age not disclosed) on (b)(6) 2026 and discovered fractured on (b)(6)2026. The stent was discovered fractured when the parents found a piece of the stent in the child's diaper and contacted the facility. An X-ray was performed and two pieces of the stent remain in the patient. The patient is scheduled for surgical removal, including a ureteroscopy and possible use of interventional radiology.No other adverse effects were reported for this incident.
Additional Manufacturer Narrative
A2 - Patient was described as "child"H3 ¿ The device is not being returned for evaluation.This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.This report is required by the FDA under 21 CFR Part 803. This report is based on unconfirmed information submitted by others. Neither the submission of this report nor any statement made in it is intended to be an admission that any Cook device is defective or malfunctioned; that a death or serious injury occurred; or that any Cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.