MalfunctionFGE

ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

Received Jul 17, 2026 · Event occurred Jul 13, 2026

Report 1820334-2026-00743 · MDR key 25857531

Device

Generic name

Fge Stents, Drains And Dilators For The Biliary Ducts

Manufacturer

Cook Inc

Model number

G51595

Catalog number

ULT6.3-35-25-P-5S-CLDM-HC

Lot number

17101335

Product problems

Difficult to Remove

Patient

Not reported

Insufficient Information

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE STIFFENER OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS DIFFICULT TO REMOVE AFTER THE CATHETER HAD BEEN PLACED IN THE PATIENT. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.