MalfunctionFAD
Biosoft duo double loop ureteral stent kit
Received Apr 22, 2026 · Event occurred Feb 6, 2026
Report 9610711-2026-00142 · MDR key 24956891
Device
Generic name
Urological Surgical Procedure Kit, Non-medicated, Single Use
Manufacturer
Coloplast A/sCatalog number
BCAGC4
Lot number
10031860_BCAGC44002
Product problems
- Separation Failure
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS NOT YET COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED ON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
ACCORDING TO THE AVAILABLE INFORMATION THE GUIDEWIRE DID NOT PASS THROUGH THE DOUBLE J STENT BECAUSE IT WAS STUCK. WHEN CHANGED, THE STENT WAS FOUND BENT. ANOTHER DOUBLE J STENT WAS SUCCESSFULLY IMPLANTED. NO PATIENT DAMAGES HAVE BEEN REPORTED.