inforMED
InjuryFGE

COTTON-LEUNG BILIARY STENT

Received Jul 14, 2026 · Event occurred Jun 19, 2026

Report 3005580113-2026-00034 · MDR key 25816367

Device

Generic name

Fge Catheter, Biliary, Diagnostic

Manufacturer

Cook Ireland Ltd

Model number

G21988

Catalog number

CLSO-7-15

Lot number

C2419022

Product problems

  • Break

Patient

NA · Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ACCORDING TO THE INITIAL REPORTER, THE PATIENT HAD A PRIOR ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH PLASTIC STENT PLACEMENT ON (B)(6) 2026. THE PHYSICIAN ATTEMPTED TO REMOVE THE FIRST 7X15 STENT AND IT BROKE AT PROXIMAL FLANGE, BUT WAS ABLE TO SUCCESSFULLY REMOVE THE 7X15 STENT USING A RAT TOOTH FORCEPS ((B)(4)). THE PHSYICIAN ATTEMPTED TO REMOVE THE SECOND 7X15 STENT AND IT BROKE AT PROXIMAL FLANGE AS WELL. THEY ATTEMPTED TO USE RAT TOOTH FORCEPS, BUT IT KEPT SLIPPING. THE PHYSICAN TRIED USING THE SNARE AND IT BROKE AGAIN. IT WAS REPORTED THAT THE SECOND 7X15 STENT STILL REMAINS INSIDE THE PATIENT'S CLEAR COMMON BILE DUCT (CBD) ((B)(4)). PATIENT IS EXPECTED TO HAVE A REPEAT ERCP TO TRY AND REMOVE.