TRUEtome Jag 44 M00583110Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729858652), received between Mar 12, 2020 and Mar 12, 2020 — classified as 1 malfunction.

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.

• MalfunctionMar 12, 2020Break; Difficult to Advance; Material Split, Cut or Torn; Break; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME JAG 44 DEVICE WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS DIFFICULTY ADVANCING THE GUIDEWIRE THROUGH THE DEVICE AND WHEN CURRENT WAS APPLIED, THE TIP WAS TORN AND THE CUTTING WIRE BROKE. NOTHING DETACHED AND FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9825179 ↗