Contour ERCP Cannula M00530870Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729099826), received between Aug 16, 2017 and Jun 14, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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. 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.

• MalfunctionJun 14, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR ERCP CANNULA WAS ATTEMPTED TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDEWIRE WAS UNABLE TO CROSS WITH THIS DEVICE. ANOTHER GUIDEWIRE WAS USED WITH THIS DEVICE, BUT THE GUIDEWIRE COULD NOT CROSS AS WELL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE PATIENT WAS REPORTED TO HAVE AN INJURY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD-FAITH EFFORTS. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 16, 2024: IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT'S HEALTH.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19538018 ↗
• MalfunctionApr 26, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR ERCP CANNULA WAS INTENDED TO BE USED IN A PROCEDURE. THE EXACT PROCEDURE DATE WAS UNKNOWN. DURING PREPARATION, IT WAS POINTED OUT BEFORE OPENING THE PACKAGE THAT A HAIR WAS NOTICED IN BETWEEN THE OUTER PACKAGING AND THE INNER DEVICE POUCH. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19198049 ↗
• MalfunctionAug 16, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CONTOUR ERCP CANNULA WAS USED IN THE DISTAL BILE DUCT DURING AN EXPANDABLE METALLIC STENT (EMS) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, A CONTOUR ERCP CANNULA AND A JAGWIRE WAS INSERTED INTO THE PANCREATIC DUCT. AFTER PLACING THE JAGWIRE, THE CANNULA WAS REMOVED FROM THE PATIENT. WHEN THE CANNULA WAS REINSERTED TO PERFORM BILE DUCT CANNULATION, IT WAS NOTICED ON THE MONITOR THAT A FRAGMENT OF THE JAGWIRE COATING WAS INSIDE THE TIP OF THE CANNULA. THE CANNULA WAS REMOVED FROM THE PATIENT AND FLUSHING WAS PERFORMED; THE JAGWIRE FRAGMENT CAME OFF. THE BILE DUCT CANNULATION WAS COMPLETED WITH THIS DEVICE AND A NON-BSC GUIDEWIRE. REPORTEDLY, THERE WAS NO RESISTANCE ENCOUNTERED WHILE MOVING THE GUIDEWIRE WITHIN THE ERCP CANNULA. HOWEVER, A BURR (ROUGH AREA) WAS NOTED AT THE TIP OF THE ERCP CANNULA, AND IT WAS THOUGHT THAT THIS MIGHT HAVE DAMAGED THE GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD". THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6798635 ↗