Cook G21466Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002214668), received between Nov 2, 2017 and Jul 3, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2019Restricted Flow rate; Restricted Flow rate

  THE DEVICE WAS USED FOR DRAINAGE DUE TO CHRONIC PANCREATITIS. DRAINAGE AND COLLECTION OF PANCREATIC JUICE COULD NOT BE MADE DUE TO A KINK IN THE CATHETER NEAR THE PAPILLA. (IT CANNOT BE DETERMINED IF THE USER NOTICED THE KINK DURING DEVICE INSERTION OR AFTER DEVICE PLACEMENT.) AFTER LEAVING THE KINKED CATHETER PLACED IN THE PANCREAS DUCT FOR A WHILE, THE USER REMOVED IT AND PLACED ANOTHER CATHETER. (THE DATE OF REMOVAL CANNOT BE DETERMINED.) THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. FDA MDR REPORTING REQUIRED: THIS EVENT MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿ SECTION 2.13 AND 2.15 AS SURGICAL INTERVENTION WAS REQUIRED TO REMOVE KINKED STENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8757793 ↗
• MalfunctionOct 4, 2018Break; Break

  THIS FILE IS BEING REPORTED UNDER THE FDA MDR MALFUNCTION PRECEDENCE "CATHETER FRACTURE/ BREAKAGE" THE NPDS CATHETER WAS MOVED TO CHANGE THE POSITION OF THE NPDS CATHETER ON THE X-RAY. THEN, THE CATHETER WAS BREAK OFF. SO THEY REMOVED THE CATHETER. THEY WENT THROUGH THE PROCEDURE AGAIN FROM THE BEGINNING. THEN, ANOTHER NPDS CATHETER WAS INSERTED AND ENDED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7933357 ↗
• MalfunctionNov 2, 2017Break; Break

  THIS FOLLOW UP MDR IS BEING SUBMITTED TO UPDATE THE INVESTIGATION CONCLUSIONS. THE DRAINAGE CATHETER CAUGHT SOMEWHERE/SOMETHING AND BROKE DURING THE PLACEMENT PROCEDURE. ADDITIONAL INFORMATION PROVIDED BY THE SALES REP ON OCT-10TH-2017: THE USER PLACED THE DRAINAGE CATHETER IN THE PATIENT WHO HAD PANCREAS CYST WHICH WAS LOCATED VERY PROXIMALLY. DUE TO THE LOCATION OF THE PANCREAS CYST, THE DRAINAGE HOLES OF THE CATHETER WERE LOCATED IN THE DUODENUM. SO HE THOUGHT IT WOULD NOT DRAIN PROPERLY AND DECIDED TO REMOVE IT. DURING REMOVING, THE CATHETER GOT CAUGHT BY SOMETHING AND STRETCHED, BUT HE KEPT PULLING IT AND THE CATHETER TIP GOT BROKE, BUT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PROCEDURE WAS ENDED WITHOUT PLACING OTHER CATHETERS. ADDITIONAL INFORMATION PROVIDED BY THE SALES REP ON OCT-27TH-2017: I TALKED THE DOCTOR WHO WAS AT THE PROCEDURE AS AN ASSISTANT DOCTOR AND OBTAINED THE INFORMATION BELOW. - THE PROXIMAL SIDE OF THE CATHETER WAS CUT AFTER PLACING IT AT THE TARGET SITE. - WHILE THE CATHETER WAS PLACED, ESWL WAS PERFORMED. DURING PERFORMING IT, THE DOCTOR DETERMINED TO REMOVED THE CATHETER BECAUSE HE THOUGHT IT WOULD NOT DRAIN PROPERLY DUE TO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6997882 ↗