TourGuide™ Steerable Sheath TG0704509Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00850232006055), received between Oct 31, 2022 and Jun 10, 2024 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2024Break; Break

  HANDLE SEPARATED FROM SHEATH PORTION OF GUIDE - WAS REMOVED FROM PATIENT WITH DIFFICULTY. DR. (B)(6) WAS USING THE TOURGUIDE TO CANNULATE THE PATIENT'S SMA VIA FEMORAL ACCESS. BEFORE HE WAS ABLE TO CANNULATE THE SMA, THE HANDLE OF THE TOURGUIDE SEPARATED FROM THE SHEATH PORTION. HE WAS ABLE TO REMOVE THE SHEATH PORTION WITH DIFFICULTY. PATIENT WAS NOT INJURED. PATIENT'S ANATOMY WAS NOT TORTUOUS. PHYSICIAN HAS EXTENSIVE EXPERIENCE WITH TOURGUIDE AS THIS WAS NOT OPERATOR ERROR. DR. (B)(6) THEN USED A COOK HIGH FLEX SHEATH AND WAS ABLE TO STENT THE SMA SUCCESSFULLY. HE WOULD LIKE THE TOURGUIDE SENT BACK FOR INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505334 ↗
• MalfunctionJun 22, 2023Mechanical Problem; Mechanical Problem

  CUSTOMER STATES THE TOURGUIDE DILATOR DOES NOT LOCK INTO THE CATHETER. ADDITIONAL INFORMATION RECEIVED 01/13/2023: CUSTOMER STATES THAT THE DILATOR DOES NOT CLICK INTO THE GUIDE AND TENDS TO SLIDE AWAY FROM THE GUIDE IF PRESSURE IS PUT ON THE DILATOR TIP. THEY HAVE REPORTED THREE CASES WITH THE SAME ISSUE. PREVIOUS CASES REPORTED (19TH OF JULY LOT DP-15547 AND 11TH OF JULY DP-15131). THE FEEDBACK IS THAT THE DILATOR DOES NOT CLICK. TWO SAMPLES ARE AVAILABLE, ONE FROM 10TH OF OCTOBER AND ONE FROM 11TH OF JULY). THE ISSUE REPORTED OCCURRED DURING THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED 02/14/2023: THIS IS IN REFERENCE TO: DP-15920. IN THE TEXT FIELD I AM WRITING THAT THIS IS A SIMILAR EVENT AS WITH 19TH OF JULY LOT DP-15547 / #979259 AND 11TH OF JULY DP-15131 / #1004350. PREVIOUS EVENTS REPORTED: EVENT REPORTED FOR (B)(4) AFFECTS DP-15920 (2022-11-29). EVENT REPORTED FOR (B)(4) AFFECTS DP-15131 (2022-07-11). EVENT REPORTED FOR CO (B)(4) AFFECTS DP-15547 (2022-07-19). AT THE TIME THE EVENT WAS REPORTED TO OSCOR, THERE WAS NO PRODUCT INFORMATION PROVIDED; THEREFORE, THE REPORT IS BEING SUBMITTED LATE AS ADDITIONAL INFORMATION WAS NEEDED TO DETERMINE REPORTABILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17181412 ↗
• MalfunctionMar 23, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THIS THE TOURGUIDE DILATOR DOES NOT ATTACH INTO THE GUIDE HUB. THE DILATOR IS LOOSE INSIDE THE GUIDE. NO KNOWN PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16598705 ↗
• MalfunctionMar 14, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THIS EVENT WAS REPORTED IN ERROR, IT IS A DUPLICATE OF REPORTED EVENT 1035166-2023-00039 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539815 ↗
• MalfunctionMar 10, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER PROVIDED ADDITIONAL INFORMATION, EVENT DATE IS 2023-02-23 AND THE DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526313 ↗
• MalfunctionFeb 13, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THIS TOURGUIDE DILATOR IS NOT CLICKING INTO THE GUIDE CATHETER HUB AT ALL. THIS IS NOT HOW THE PRODUCT LOOKED OR FELT LIKE BEFORE. THERE IS NO WAY TO GET THE DILATOR TO LOCK INTO ITS PLACE IN THE GUIDE AND THE DILATOR IS MOVING FREELY IN THE CATHETER. THE SLIGHTEST PUSH AT THE END OF THE DILATOR (MIMICKING VESSEL WALL IN CASE OF AN INSERTION) IS MAKING THE DILATOR SLIDE AWAY FROM THE GUIDE CATHETER. THIS DEVICE WAS NOT USED IN A PROCEDURE, ON A PATIENT, BY A PHYSICIAN OR BY A HEALTHCARE PROFESSIONAL. THE DEVICE INVOLVED IN THIS COMPLAINT WAS REPORTED FROM THE DISTRIBUTORS' REPRESENTATIVE, FROM THEIR OWN DEMONSTRATION DEVICE INVENTORY. ON (B)(6) 2023 THE CUSTOMER REPORTED THAT BEFORE MEETING WITH A CUSTOMER ON (B)(6) 2023, SHE ATTEMPTED TO USE HER DEMONSTRATION DEVICE AND DISCOVERED THE DEVICE WAS NOT WORKING CORRECTLY, AS STATED ABOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16368630 ↗
• MalfunctionDec 22, 2022Difficult to Insert; Material Too Rigid or Stiff; Deformation Due to Compressive Stress; Difficult to Insert; Material Too Rigid or Stiff; Deformation Due to Compressive Stress

  IT WAS REPORTED THE 8FR TOURGUIDE CATHETER WAS USED IN AN EXTREMELY TORTUOUS ANATOMY. IT WAS HARD TO INSERT AND USE IN THE ILIAC VESSEL. THE DOCTOR TRIED TO BE GENTLE AND CAREFUL, HOWEVER THE CATHETER KINKED AT THE PROXIMAL END CLOSE TO THE HANDLE. EVENTUALLY THE KINKED CATHETER BROKE, AND HAD TO BE CUT TO REMOVE IT. THE CUSTOMER REPORTED THE EVENT DATE AND LOT NUMBER AS UNKNOWN. THE REPORTED 8FR TOURGUIDE IS NOT A VALID MODEL NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16034787 ↗
• InjuryDec 1, 2022Unintended Movement; Unintended Movement

  CUSTOMER SAYS THE DILATOR DID NOT STAY INSIDE OF THE CATHETER (THEY ALSO SAID IT DOES NOT STAY CLICKED WHEN THE DILATOR IS PUSHED INTO THE CATHETER AND IF IT DOES, THEN IT IS DIFFICULT TO REMOVE THE DILATOR FROM INSIDE THE CATHETER). WHEN THE DILATOR DID SLIDE OUT OF THE CATHETER, THE CATHETER CAUSED DAMAGE ON THE VESSEL AND THEY HAD TO REPAIR IT WITH OPEN SURGERY.

  Patient problems: Vascular Dissection

  MAUDE report 15899220 ↗
• InjuryOct 31, 2022No Apparent Adverse Event; No Apparent Adverse Event

  DETAILS OF PRODUCT ISSUE IS UNKNOWN. HOWEVER, THESE DETAILS WERE PROVIDED ABOUT WHAT HAPPENED TO THE PATIENT OR PRODUCT(S) RELEVANT TO THIS EVENT: NO FLEXIBILITY OF THE DM INSIDE THE AORTA THUS NOT BEING ABLE TO ACCESS THE OSTIUM OF THE RENAL ARTERY. NEED FOR A DIFFERENT CHOICE OF INTERVENTION PROTOCOL FOR THE PATIENT TO BE REPROGRAMMED. REPORTED ALLEGED EVENT HAS NOT BEEN RESOLVED. FUTURE TREATMENT FOR PATIENT IS PLANNED, BUT TYPE OF TREATMENT IS UNKNOWN. IT IS UNKNOWN IF THERE ARE ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. CLINICAL OUTCOME - INTERVENTION. SUBMISSION FOR ADMINISTRATIVE PURPOSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15699026 ↗