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 LtdModel number
G21988Catalog 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.