Flexima™ M001271870Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729323389), received between Nov 30, 2018 and Nov 30, 2018 — classified as 1 malfunction.

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

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2018Break; Entrapment of Device; Difficult to Remove; Material Deformation; Break; Entrapment of Device; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THE PATIENT PRESENTED WITH A PANCREATIC NEOPLASIA WITH TUMOR RECURRENCE AND INTRAHEPATIC BILIARY TRACT DILATATION. A FLEXIMA CATHETER DRAINAGE WAS SELECTED FOR USE. DURING THE PROCEDURE AFTER PUNCTURE OF THE ULTRASOUND GUIDED, THE PERCUTANEOUS BILE DUCT, THE GUIDEWIRE AND THE INTRODUCER SHEATH WERE INTRODUCED AND PASSED. THE PASSAGE IN THE ABDOMINAL WALL WAS DIFFICULT DUE TO ADHESIONS OF POSTOPERATIVE CHANGES. WHEN THE GUIDEWIRE WAS REMOVED FOR FURTHER WITHDRAWAL OF THE DILATOR, IT WAS NOTED THAT IT WAS ATTACHED TO THE END OF THE DILATOR. SEVERAL MANEUVERS WERE ATTEMPTED TO REMOVE THE GUIDEWIRE. HOWEVER, THIS ENDED UP BURSTING THE DEVICE. FINALLY, EVERY SET INCLUDING GUIDE WIRE, INTRODUCER AND DILATOR WERE REMOVED WITHOUT COMPLICATIONS. A NEW LAPAROTOMY PROCEDURE WAS PERFORMED DURING ULTRASOUND. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT CONDITION POST PROCEDURE WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8120831 ↗