Contour ERCP Cannula M00530880Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729099833), received between Aug 2, 2022 and Aug 2, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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.

• MalfunctionAug 2, 2022Difficult to Advance; Device Contamination with Chemical or Other Material; Material Deformation; Difficult to Advance; Device Contamination with Chemical or Other Material; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR ERCP CANNULA WAS USED IN THE COMMON BILE DUCT DURING A PROCEDURE PERFORMED ON (B)(6), 2022. DURING THE PROCEDURE, THIS CONTOUR ERCP CANNULA WAS USED WITH A NON BSC GUIDEWIRE DURING CANNULATION. WHEN THE CONTOUR ERCP CANNULA WAS ATTEMPTED TO BE PULLED OUT LEAVING THE GUIDEWIRE IN PLACE, IT WAS OBSERVED THAT THERE WAS DIFFICULTY REMOVING THE DEVICE; HENCE, THE REPLACEMENT OF THE DEVICE COULD NOT BE PERFORMED. THE PROCEDURE WAS COMPLETED ANOTHER OF THE SAME DEVICE. IT WAS REPORTED THAT THE GUIDEWIRE WAS ADVANCED WITHOUT ANY PROBLEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: THE PRODUCT ANALYSIS REVEALED THERE WAS AN UNKNOWN WHITE AND BLACK RESIDUE IN THE DEVICE. PLEASE REFER TO BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15152915 ↗