TourGuide™ Steerable Sheath TG0709009Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169936249), received between Sep 3, 2020 and Sep 3, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 71 MM ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2018. CT WAS PERFORMED ON (B)(6) 2021, DUE TO ABDOMINAL PAIN, WHERE AN ENDOLEAK TYPE 1A WAS OBSERVED. IN ADDITION, DISSECTION WAS OBSERVED BY IVUS AS WELL AS ANGIOGRAPHY, EXTENDING FROM THE LEFT SUBCLAVIAN TO THE LEVEL OF THE CELIAC. THE PHYSICIAN BELIEVED THAT THE DISSECTION WAS PROBABLY CAUSED BY THE SHEATHS USED IN THE SNORKELS IN CONCERT WITH THE PATIENT'S POSSIBLE CONNECTIVE TISSUE DISORDER. AS PER THE PHYSICIAN, CAUSE OF THE ENDOLEAK EVENT WAS THAT THE PATIENT MAY HAVE A DEGENERATIVE DISEASE DUE TO THE FACT THAT EVERY PLACE WHERE THE STENT GRAFT TOUCHED AORTIC WALL, WE HAVE HAD DEGENERATION AND GROWTH OVER THE LAST 3 YEARS. THE PATIENT IS NOT AN OPEN SURGICAL CANDIDATE, OR SHE WOULD RECEIVE AN OPEN REPAIR. THE DISSECTION WAS NOT OBSERVED UNTIL THE END OF THE INTERVENTION. CAUSE OF THE DISSECTION IS UNKNOWN. THE USER DIDN'T REPORT DEVICE PERFORMANCE ISSUE. NO FURTHER TREATMENT IS PLANNED AT THIS TIME.

  Patient problems: Aneurysm; Vascular Dissection

  MAUDE report 12423290 ↗
• InjuryMar 4, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT 2 DAYS POST THE INDEX PROCEDURE, ON THE (B)(6) 2021 PATIENT HAD THROMBOSED LEG AND INTERVENTION PERFORMED TO TREAT THROMBOSED LEGS. PATIENT DIED FROM MULTI ORGAN FAILURE AFTER REINTERVENTION. AS PER PHYSICIAN PATIENT DEATH IS RELATED TO THE PROCEDURE AND NOT DEVICE. TOURGUIDE STEERABLE GUIDING SHEATH WORK AS INTENDED AND NO PRODUCT MALFUNCTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Thromboembolism

  MAUDE report 11417523 ↗
• InjuryMar 4, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT 2 DAYS POST THE INDEX PROCEDURE, ON THE (B)(6) 2021 PATIENT HAD THROMBOSED LEG AND INTERVENTION PERFORMED TO TREAT THROMBOSED LEGS. PATIENT DIED FROM MULTI ORGAN FAILURE AFTER REINTERVENTION. AS PER PHYSICIAN PATIENT DEATH IS RELATED TO THE PROCEDURE AND NOT DEVICE. TOURGUIDE STEERABLE GUIDING SHEATH WORK AS INTENDED AND NO PRODUCT MALFUNCTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Thromboembolism

  MAUDE report 11417519 ↗
• MalfunctionSep 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SHEATH HUB DISCONNECTED AT THE END OF THE PROCEDURE WHILE REMOVING THE SHEATH FROM THE PATIENT BODY. THE USER WAS ATTEMPTING TO CANNULATE A VISCERAL VESSEL AND MANEUVERING THE TOUR GUIDE. THERE WERE NO PATIENT SIDE EFFECTS REPORTED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER SHEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10490742 ↗