COTTON-LEUNG BILIARY STENT
Received Jul 20, 2026 · Event occurred Jun 19, 2026
Report 3001845648-2026-00294 · MDR key 25874075
Device
Generic name
Fge-stents, Drains And Dilators For The Biliary Ducts
Manufacturer
Cook Ireland LtdModel number
G21988Catalog number
CLSO-7-15
Lot number
C2418912
Product problems
- Break
Patient
NA · Female
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
Description of Event or Problem
DESCRIPTION OF EVENT PATIENT HAS HAD A PRIOR ERCP WITH PLASTIC STENT PLACEMENT [(B)(6) 2026]. (B)(4). ATTEMPTED TO REMOVE FIRST 7X15 STENT AND IT BROKE AT PROXIMAL FLANGE. WAS ABLE TO SUCCESSFULLY REMOVE THIS 7X15 WITH RAT TOOTH FORCEPS. (B)(4). ATTEMPTED TO REMOVE SECOND 7X15 STENT AND IT BROKE AT PROXIMAL FLANGE. ATTEMPTED TO USE RAT TOOTH FORCEPS BUT IT KEPT SLIPPING. USED SNARE AGAIN AND IT BROKE AGAIN. SECOND 7X15 STENT STILL INSIDE PATIENTS CBD. PATIENT WILL HAVE A REPEAT ERCP TO TRY AND REMOVE. __________________________________________________________________ PATIENT OUTCOME PLASTIC STENT 7X15 STILL INSIDE PATIENTS CBD PATIENT WILL HAVE A REPEAT ERCP TO TRY AND REMOVE.