TourGuide™ Steerable Sheath TG0854517Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850232006093), received between Aug 5, 2021 and Aug 5, 2021 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 5, 2021Break; Material Fragmentation; Material Integrity Problem; Break; Material Fragmentation; Material Integrity Problem

  IT WAS REPORTED THAT DURING A FENESTRATED ENDOVASCULAR AORTIC REPAIR (FEVAR) PROCEDURE, THE DOCTOR INTRODUCED THE TOURGUIDE IN THE PATIENT AND PLACED IT IN FRONT OF A RENAL ARTERY TO CATHETERIZE IT. THE DOCTOR REMOVED THE WIRE AND THE SHEATH AS USUAL. HE TURNED THE WHEEL TO CHANGE THE ORIENTATION AND THE PROXIMAL EXTREMITY BUT AFTER A TURN, EVERYTHING STOP WORKING. HE REMOVED THE TOURGUIDE AND SAW THAT THE KEVLAR WIRE USED TO GO THROUGH THE LAYER OF THE TOURGUIDE WAS OUTSIDE, MEANING THERE WAS A HOLE IN THE SHEATH WHERE THE WIRE HAD PROTRUDED ONE CENTIMETER OUTSIDE OF THE SHEATH. TO CONTINUE THE PROCEDURE, HE USED ANOTHER TOURGUIDE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12280511 ↗