TourGuide Steerable SheathRecalls & reported problems across all models

We found 9 models of TourGuide Steerable Sheath by Oscor Inc. in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Mar 30, 2020 and Dec 9, 2024 — classified as 1 death, 5 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (13 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported TourGuide Steerable Sheath problems

TourGuide Steerable Sheath models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TourGuide™ Steerable Sheath TG0704509

  INTRODUCER, CATHETER
  9 reports
• TourGuide™ Steerable Sheath TG0655509

  INTRODUCER, CATHETER
  8 reports
• TourGuide™ Steerable Sheath TG0654509

  INTRODUCER, CATHETER
  5 reports
• TourGuide™ Steerable Sheath TG0709009

  INTRODUCER, CATHETER
  4 reports
• TourGuide™ Steerable Sheath TG0705509

  INTRODUCER, CATHETER
  4 reports
• TourGuide™ Steerable Sheath TG0705517

  INTRODUCER, CATHETER
  1 death3 reports
• TourGuide™ Steerable Sheath TG0855517

  INTRODUCER, CATHETER
  2 reports
• TourGuide™ Steerable Sheath TG0704517

  INTRODUCER, CATHETER
  1 report
• TourGuide™ Steerable Sheath TG0854517

  INTRODUCER, CATHETER
  1 report

Recent TourGuide Steerable Sheath adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DURING THE PROCEDURE THERE WAS A LEAK AT THE STOPCOCK. THE PRODUCT IS STILL AT THE HOSPITAL, IF NEEDED IT CAN BE RETURNED OTHERWISE IT WILL BE DESTROYED. THE PATIENT RECEIVED TREATMENT ON (B)(6) 2024. PATIENT STATUS AT TIME OF THIS REPORT ALIVE - NO INJURY. THE ISSUE WAS RESOLVED BY USING ANOTHER TOURGUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20886453 ↗
• 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 10, 2024Material Integrity Problem; Material Integrity Problem

  THE CUSTOMER STATED A 62-YEAR-OLD PATIENT TREATED FOR LEFT RENAL ARTERY RECANALIZATION. DURING THE SURGICAL PROCEDURE, THE SHEATH FOLDED IN SITU (IN THE ORIGINAL PLACE). DIFFICULTIES IN PERFORMING THE SURGICAL PROCEDURE. ITS UNCLEAR WHAT THE USER MEANT BY THE SHEATH FOLDED IN SITU. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN INFORMATION RELATED TO THIS CASE; HOWEVER, NO INFORMATION WAS PROVIDED BY CUSTOMER. PROCEDURE WAS NOT CONTINUED DUE TO UNSATISFACTORY RESULTS OF THE NEPHOGRAM SHOWING A VERY POOR-QUALITY DIFFUSION, UNRELATED TO THE FOLDING. NO ADVERSE EVENT WITH PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19500156 ↗
• MalfunctionSep 7, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THE DILATOR DOES NOT "CLICK' SHUT INTO THE TOURGUIDE. THUS, IT DOES NOT STAY IN PLACE WHILE ADVANCING INTO THE PATIENT. THE EVENT OCCURRED DURING THE PROCEDURE AND THE PATIENT RECEIVED TREATMENT. THE CUSTOMER STATED THE ISSUE HAS NOT RESOLVED. THE HEALTHCARE PROFESSIONAL STATED THE CAUSE OF THE EVENT WAS ERROR OF GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17699702 ↗
• 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 ↗
• 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, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE EVENT OCCURRED DURING PRE-OP, THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE LEAKED FROM THE VALVE, AT THE BEGINNING OF THE HOSE ON THE SIDE WHERE THE TAP IS LOCATED AND AT THE TURNING MECHANISM. THE ISSUE WAS RESOLVED USING A NEW PRODUCT. THE PATIENT DID NOT RECEIVE TREATMENT. THE DEVICE IS EXPECTED TO BE RETURNED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600008 ↗
• 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 ↗
• MalfunctionMar 9, 2023Mechanical Problem; Mechanical Problem

  CUSTOMER SAYS 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. THE PATIENT HAS NOT RECEIVED TREATMENT. THERE IS NO KNOWN PATIENT HARM REPORTED. THE ISSUE HAS NOT BEEN RESOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16513835 ↗
• MalfunctionMar 8, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED DURING A PROCEDURE FOR SMA STENTING, THE SIDEARM OF THIS 6.5F TOUR GUIDE SHEATH FELL OFF AND STARTED LEAKING BLOOD (APPROXIMATELY 100MLS). NO BLOOD TRANSFUSION WAS REQUIRED. IN ORDER TO CONTROL THE BLOOD LOSS, THE PHYSICIAN PLACED FINGER OVER HOLE IN SHEATH, WHILE AN EXCHANGE FOR A NEW 6.5F TOURGUIDE SHEATH (SAME MODEL) WAS COMPLETED. THE PROCEDURE WAS DELAYED FOR 10 MINUTES, TO FIND AND EXCHANGE A NEW SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE CAUSE OF THE EVENT IS UNKNOWN. THERE WERE NO REPORTED PATIENT SYMPTOMS, OR COMPLICATIONS ASSOCIATED WITH THIS EVENT (ALIVE, NO INJURY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16503372 ↗
• MalfunctionMar 6, 2023Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  HEMOSTATIC VALVE FELL OUT AND BLOOD LEAKED ONTO THE TABLE. USED NEW DEVICE TO FINISH PROCEDURE AS NORMAL. THE PATIENT RECEIVED TREATMENT. NO INJURY TO PATIENT. ADDITIONAL PATIENT INFORMATION RECEIVED: PATIENT RECEIVED COELIAC ARTERY ANEURYSM STENT GRAFTING. BLOOD LOST REPORTED AS 100MLS - ISH. 5F STANDARD SHEATH INTRODUCED THROUGH THE END OF THE DEVICE (WHERE THE HEMOSTATIC VALVE WAS) TO STOP THE BLEEDING AND ALLOW A SUPPORTIVE WIRE TO BE INTRODUCED TO FACILITATE EXCHANGE. SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 10 MINS DELAY FINDING A NEW SHEATH - PUT IN SUPPORTING GUIDEWIRE AND EXCHANGE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16488615 ↗
• MalfunctionFeb 14, 2023Mechanical Problem; Mechanical Problem

  THE DILATOR DOES NOT CONNECT TO THE GUIDE. THERE IS NOTHING THAT IT CAN STAY CONNECTED TO. THE DILATOR IS COMPLETELY LOOSE AND FREE RIDING AND IMMEDIATELY UPON TOUCHING ANYTHING AT THE END IT WILL SLIDE INSIDE OF THE GUIDE. THE PATIENT HAS NOT AND WILL NOT RECEIVE TREATMENT. THE HANDLE IS OUTSIDE OF THE PATIENT AND THE COMPLAINT IS ABOUT THE DILATOR-TO-GUIDE CONNECTION OUTSIDE OF THE PATIENT´S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375486 ↗
• 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 ↗

Other Oscor Inc. products

• Introducer Kit for Impella11 models · 1,326 reports · 9 recalls
• Guidestar Steerable Guiding Sheath2 models · 103 reports · 1 recall
• SafeSheath II14 models · 146 reports
• Destino Twist Steerable Guiding Sheath19 models · 45 reports · 1 recall
• SafeSheath Ultra Lite3 models · 24 reports · 1 recall
• Occlutech Delivery Set III10 models · 39 reports
• DiRex Steerable Sheath7 models · 22 reports
• Lead Adaptor3 models · 20 reports