TUMOR STENT DOUBLE LOOP URETERAL STENT KIT
Received Jun 17, 2026 · Event occurred May 1, 2025
Report 9610711-2026-00191 · MDR key 25532657
Device
Generic name
Urological Surgical Procedure Kit, Non-medicated, Single Use
Manufacturer
Coloplast A/sCatalog number
BCCG75
Lot number
10467884_BCCG754002
Product problems
- Device Stenosis
Patient
NA · Unknown
- Renal Failure
Narrative
Description of Event or Problem
ACCORDING TO THE AVAILABLE INFORMATION, CLOGGED STENTS REQUIRING EARLY REPLACEMENT. STENT HAD TOTAL OBSTRUCTION. THE STENTS WERE PLACED ON A SCHEDULED BASIS BUT CHANGED ON AN EMERGENCY BASIS. 1 TO MULTIPLE REHOSPITALIZATIONS PER PATIENT DUE TO ACUTE RENAL FAILURE. EARLY REPLACEMENT OF STENTS UNDER GENERAL OR LOCAL ANESTHESIA IN CANCER PATIENTS. AVERAGE TIME BEFORE OBSTRUCTION WAS OBSERVED WAS 89 DAYS BETWEEN THE PLACEMENT OF THE FIRST CATHETER AND ITS EARLY REPLACEMENT. IMPLANTATIONS WERE MOSTLY FOR BLADDER TUMORS, MOSTLY EXTERNAL COMPRESSION. DEVICE WAS EXPOSED TO UNUSUAL CONDITIONS AND FREE OF ANY VISIBLE DEFECTS UPON OPENING.
Additional Manufacturer Narrative
THE INVESTIGATION IS NOT YET COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED ON COMPLETION OF THE INVESTIGATION. THE ADDITIONAL DEVICES REFERENCED IN B5 ARE CAPTURED UNDER SEPARATE REPORTS.