Geenen G21379Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002213791), received between Jan 16, 2018 and Jan 16, 2018 — classified as 1 injury.

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. 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.

• InjuryJan 16, 2018Break; Break

  THIS INITIAL MDR IS BEING SUBMITTED DUE TO SERIOUS INJURY. THE PLANNED PROCEDURE WAS AN EXCHANGE OF THE PANCREATIC PLASTIC STENT PLACED ON (B)(6) 2017. THE SNARE TO PULL THE STENT COULD BE PLACED AROUND THE BODY OF THE STENT AND WAS CLOSED SUCCESSFULLY. WHEN PULLING LIGHTLY ON THE STENT THE STENT TORE AND THE PROXIMAL 2 CM OF THE STENT REMAINED IN THE PANCREATIC DUCT. THE REST OF THE STENT WAS PULLED OUT SUCCESSFULLY. THE CUSTOMER TRIED TO RETRIEVE THE REMAINING PART OF STENT, BUT WAS NOT SUCCESSFUL. THEY TRIED WITH STENT RETRIEVER, BUT NO SUCCESS (CANNOT ENTER A WIRE INTO THE STENT LUMEN). THE NEXT DAY THEY TRIED AGAIN, BUT NOT SUCCESSFUL WITH THE FOLLOWING METHODS: STRAIGHT WIRE, ANGLED WIRE, STENT RETRIEVER ONLY (NOT THROUGH THE LUMEN OF THE STENT NOR SIDEWAYS) AND GRASPING FORCEPS. AFTER INJECTING CONTRAST THE REMAINING STENT SEEMED OPEN AND THE DUCTUS WIRSUNGIANUS APPEARED UNEVENLY DILATED. PATIENT HAS LEFT THE HOSPITAL, BECAUSE THERE IS A PLANNED CHRISTMAS HOLIDAY TRAVEL. THE STENT GOT TORN OFF DURING ROUTINE EXCHANGE. ABOUT 1.5 CM REMAINED IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7193857 ↗