Advanix™ Pancreatic Stent Kit M00537470Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729856252), received between Mar 19, 2018 and Mar 19, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Kinked” (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 18, 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.

• MalfunctionMar 19, 2018Kinked; Kinked

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT KIT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE PANCREATIC DUCT, PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE THE STENT IN TO THE PANCREATIC DUCT BUT THE PUSH CATHETER AND THE STENT DID NOT COME OUT FROM THE SCOPE CHANNEL OF THE ENDOSCOPE. THE PHYSICIAN REMOVED THE GUIDEWIRE AND THE STENT WAS DETACHED IN THE DUODENUM WHICH WAS RETRIEVED USING A FORCEPS. THE PROCEDURE WAS COMPLETED WITHOUT PLACING THE STENT. 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; STENT KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7349236 ↗