TourGuide™ Steerable Sheath TG0705509Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00850232006079), received between Mar 30, 2020 and Jun 7, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE ORANGE ANTI-RETURN VALVE INTRODUCER DOES NOT WORK; RESULTING IN BLOOD REFLUX. THE PERSON OR PATIENT INVOLVED IS SHOWING AN INCREASE IN BLOOD LOSS. PROCEDURE COMPLETED WITH ANOTHER DEVICE. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11947263 ↗
• MalfunctionSep 9, 2020Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING THE STELLAR AFIB PVI PROCEDURE, THE SHEATH HUB BROKE. THE USER WAS TRYING TO CANNULATE THE RIPV, AND BLOOD LEAKAGE WAS NOTICED THROUGH HEMOSTATIC VALVE. THE AMOUNT OF BLOOD LOSS IS UNKNOWN, AND NO MEDICAL OR SURGICAL INTERVENTION IS REQUIRED TO CONTROL BLOOD LOSS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER OSCOR SHEATH. THERE WERE NO PATIENT SIDE EFFECTS OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10511065 ↗
• MalfunctionSep 4, 2020Break; Break

  ON (B)(6) 2020, THE CUSTOMER REPORTED WE DON'T HAVE THE TOUR GUIDE AT THE PHARMACY. IT UNFORTUNATELY WASN'T KEPT BY THE OPERATING ROOM TEAM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10497828 ↗
• MalfunctionMar 30, 2020Break; Break

  DURING A FEVAR PROCEDURE THE TOURGUIDE SHEATH USED WAS BEING PULLED FROM THE PATIENT OUT OF A LARGER 20 FRENCH SHEATH WHEN THE TIP OF THE TOURGUIDE SHEATH BROKE OFF. THERE WAS A LITTLE RESISTANCE BRINGING IT OUT BEFORE IT BROKE BUT NOTHING TOO ABNORMAL. THE CUSTOMER SPOKE WITH THE HCP AND THE CAUSE OF THE EVENT CANNOT BE DETERMINED. THE TIP OF THE SHEATH CLOSE TO THE RADIOPAQUE MARKER WAS BROKEN OFF COMPLETELY FROM THE REST OF THE SHEATH. THE PHYSICIAN USED A 4 MM PTA BALLOON TO TRAP IT AND PULL IT OUT OF THE 20 FRENCH COOK SHEATH THAT WAS IN PLACE. THE DOCTOR STATED HE WAS DOING A PLANNED FEVAR (FENESTRATED EVAR REPAIR) ON THE PATIENT AND USES TOUR GUIDE TO CANNULATE THE VISCERAL VESSELS AND PLACED HIS STENTS IN THE RENAL ARTERIES. HE STATED THAT THE WIRE WAS STILL IN AND THE BROKEN OFF PIECE WAS STILL ON THE WIRE. HE BLEW UP THE BALLOON INSIDE OF THE BROKEN TIP AND WAS ABLE TO USE THE BALLOON TO GET THE TIP OF THE PATIENT AND THROUGH THE 20 FR SHEATH. THE PATIENT HAD NO COMPLICATIONS FROM THE BROKEN TIP OF THE SHEATH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9901110 ↗