Advanix™ Pancreatic Stent M00536370Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729857310), received between Jul 18, 2018 and Jul 18, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018, WHILE THE ENDOSCOPE WAS BEING PRE-CLEANED AND BRUSHED IN PREPARATION FOR A PROCEDURE, AN ADVANIX PANCREATIC STENT CAME OUT OF THE WORKING CHANNEL AS THE CLEANING BRUSH WAS BEING PUSHED DOWN THE BIOPSY CHANNEL. THE STENT WAS NOT INTRODUCED INTO THE PATIENT DURING THE PROCEDURE, AND IT IS SUSPECTED THAT THE STENT WAS LODGED IN THE SCOPE BEFORE THE PROCEDURE HAD STARTED. 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 FINE. FOLLOWING THE PROCEDURE, THE PATIENT WAS GIVEN A PHONE CALL AND WAS INFORMED OF THE POTENTIAL RISK OF INFECTION DUE TO THE DEVICE ISSUE. THERE WAS NO FURTHER ACTION REPORTED FOR THIS PATIENT. NO TREATMENT OR HOSPITAL STAY WERE REPORTED DUE TO THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7698450 ↗