Tumor Stent double loop ureteral stent kit
Received Jul 27, 2026 · Event occurred May 1, 2025
Report 9610711-2026-00221 · MDR key 50035179
Device
Generic name
Urological Surgical Procedure Kit, Non-medicated, Single Use
Manufacturer
Coloplast A/sCatalog number
BCCG74
Lot number
10740654_BCCG744002
Product problems
- Device Stenosis
Patient
Not reported
- Renal Failure
Narrative
Description of Event or Problem
According to the available information, clogged stents requiring early replacement. Stent was placed on a scheduled basis and procedure was standardized and were changed on an emergency basis. Consequences: 1 to multiple rehospitalizations per patient due to acute renal failure. Early replacement of stents under general or local anesthesia in cancer patients. Patient experienced significant hematuria.
Additional Manufacturer Narrative
The investigation is not yet complete, a follow up report will be submitted on completion of the investigation.