TourGuide™ Steerable Sheath TG0705517Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850232006086), received between Aug 15, 2022 and Aug 17, 2023 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathAug 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE FEMALE PATIENT WAS TRANSPORTED FROM ANOTHER HOSPITAL. SHE CAME IN WITH ISCHEMIC MESENTERIC ARTERIES AND HAD GONE THROUGH A COLECTOMY FROM THE PRIOR HOSPITAL. SHE CAME WITH AN OPEN ABDOMEN AND THE TASK FOR THE PHYSICIAN WAS TO TRY TO MAKE SOME REVASCULARIZATION TO THE REMAINING BOWELS. HOWEVER, BECAUSE OF THE PATIENT'S CONDITION, THEY WERE NOT ABLE TO PERFORM ANY REVASCULARIZATION. THE PATIENT DIED THE NIGHT AFTER THE PROCEDURE BECAUSE OF THE ISCHEMIC MESENTERIC CONDITION.PER THE PHYSICIAN CAUSE OF THE PATIENT DEATH IS NOT RELATED TO DEVICE USE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17568722 ↗
• MalfunctionAug 15, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT OUR USUAL PRACTICE IS TO USE THE TOURGUIDE STEERABLE SHEATH TO CANNULATED THE VISCERAL ARTERIES OF THE FENESTRATED AORTIC STENT GRAFT AND DELIVER A VISCERAL STENT GRAFT. ON THIS OCCASION WE NOTICED THAT THE INTRODUCER/DILATOR DID NOT SECURELY CLICK INTO THE HEMOSTATIC VALVE OF THE SHEATH. USUALLY, OUR EXPECTATION IS THERE IS A SECURE ATTACHMENT OF THE INTRODUCER/DILATOR TO THE SHEATH. WE NOTICED THIS AND MANUALLY HELD THE INTRODUCER AND SHEATH TOGETHER. THE TOURGUIDE THEN FUNCTIONED AS EXPECTED AND RIGHT RENAL ARTERY WAS CANNULATED. DUE TO VESSEL TORTUOSITY IT WAS NECESSARY TO USE A SECOND TOURGUIDE FOR THE SMA. THE EXACT SAME FINDING OF THE INTRODUCER/DILATOR DID NOT ATTACH. AGAIN WE CONTINUED TO USE THE SHEATH WITHOUT ISSUE. TOURGUIDE INTRODUCER DID NOT "CLICK IN" TO THE HUB OF THE HEMOSTATIC VALVE DURING A FENESTRATED EVAR PROCEDURE. I WOULD JUST LIKE TO HIGHLIGHT THIS ISSUE AS WE THINK IT IS A CHANGE FROM OUR USUAL EXPECTATION OF THIS SHEATH. I HAVE LOOKED AT A DEMO SHEATH I HAVE FOR TEACHING THE INTRODUCER/DILATOR ON THAT ONE DOES CLICK IN SECURELY TO THE HEMOSTATIC VALVE AS EXPECTED. THERE WAS NO CLINICAL ISSUE AS WE SPOTTED THIS AND THE CASE WENT WELL AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15229124 ↗
• MalfunctionAug 15, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT OUR USUAL PRACTICE IS TO USE THE TOURGUIDE STEERABLE SHEATH TO CANNULATED THE VISCERAL ARTERIES OF THE FENESTRATED AORTIC STENT GRAFT AND DELIVER A VISCERAL STENT GRAFT. ON THIS OCCASION WE NOTICED THAT THE INTRODUCER/DILATOR DID NOT SECURELY CLICK INTO THE HEMOSTATIC VALVE OF THE SHEATH. USUALLY, OUR EXPECTATION IS THERE IS A SECURE ATTACHMENT OF THE INTRODUCER/DILATOR TO THE SHEATH. WE NOTICED THIS AND MANUALLY HELD THE INTRODUCER AND SHEATH TOGETHER. THE TOURGUIDE THEN FUNCTIONED AS EXPECTED AND RIGHT RENAL ARTERY WAS CANNULATED. DUE TO VESSEL TORTUOSITY IT WAS NECESSARY TO USE A SECOND TOURGUIDE FOR THE SMA. THE EXACT SAME FINDING OF THE INTRODUCER/DILATOR DID NOT ATTACH. AGAIN WE CONTINUED TO USE THE SHEATH WITHOUT ISSUE. TOURGUIDE INTRODUCER DID NOT "CLICK IN" TO THE HUB OF THE HEMOSTATIC VALVE DURING A FENESTRATED EVAR PROCEDURE. I WOULD JUST LIKE TO HIGHLIGHT THIS ISSUE AS WE THINK IT IS A CHANGE FROM OUR USUAL EXPECTATION OF THIS SHEATH. I HAVE LOOKED AT A DEMO SHEATH I HAVE FOR TEACHING THE INTRODUCER/DILATOR ON THAT ONE DOES CLICK IN SECURELY TO THE HEMOSTATIC VALVE AS EXPECTED. THERE WAS NO CLINICAL ISSUE AS WE SPOTTED THIS AND THE CASE WENT WELL AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15229053 ↗