Cook G13353Recalls & reported problems
Cook Incorporated · Biliary Drainage Catheter Ultrathane · Class U · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002133532), received between Nov 15, 2017 and May 24, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Advance1
- Difficult to Remove1
- Fluid/Blood Leak1
- Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 24, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN 'ULTRATHANE EXTENDED LENGTH SIDEPORTS BILIARY DRAINAGE CATHETER' LEAKED JUST AFTER PLACEMENT. THE LEAK WAS NOTED "AT THE HUB WHERE THE CATHETER ENTERS THE HUB". A NEW DRAIN WAS PLACED IMMEDIATELY TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19396044 ↗MalfunctionMar 31, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance
SOMETIME DURING THE WEEK OF (B)(6) 2023, AN UNKNOWN PATIENT REQUIRED AN ULTRATHANE EXTENDED LENGTH SIDEPORTS BILIARY DRAINAGE CATHETER. IT WAS REPORTED THAT THE BLUE FLEXIBLE STIFFENER WAS DIFFICULT TO ADVANCE INTO THE DRAINAGE CATHETER AND THEN COULD NOT BE REMOVED ONCE IT WAS INSERTED INTO THE DRAIN. THE DRAIN AND STIFFENER WERE REMOVED, AND A SECOND DRAIN WAS OPENED, ENCOUNTERING THE SAME ISSUE. IT WAS NOT STATED HOW THE PROCEDURE WAS COMPLETED, BUT NO ADVERSE EVENTS WERE REPORTED FOR THE PATIENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16656417 ↗InjuryNov 15, 2017Sticking
IT WAS REPORTED THAT DR. (B)(6) HAD THREE CASES IN THE PASSED TWO WEEKS IN WHICH THE WIRE AND STIFFENER WERE STUCK INSIDE THE DRAINAGE CATHETER. THE MOST RECENT CASE ADDED AN ADDITIONAL HOUR TO THEIR PROCEDURE AND ANESTHESIA TIME.
Patient problems: No Code Available
MAUDE report 7034995 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.