TrailBlazer™ SC-035-090 (UDI 00821684058039)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00821684058039), received between May 18, 2017 and Nov 1, 2018 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K092299); they may or may not involve this specific model.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A TRAILBLAZER TO TREAT A MODERATELY CALCIFIED LESION WITH 75% STENOSIS IN THE PROXIMAL RIGHT ILIAC ARTERY. A NON-MEDTRONIC 7FR SHEATH AND A NON-MEDTRONIC 0.35X260 GUIDEWIRE WERE USED. IFU WAS FOLLOWED PRE, DURING AND POST PROCEDURE. THE CATHETER WAS BEING REMOVED OVER THE GUIDEWIRE WHEN RESISTANCE WAS FELT AS THE DEVICE CAME OVER THE AORTIC BIFURCATION. THE PHYSICIAN CONTINUED TO PULL AND THE CATHETER BROKE IN TWO. CATHETER SEGMENTS GOT STUCK ON THE GUIDEWIRE AND WERE RETRIEVED WITH A NON-MEDTRONIC SNARE SYSTEM. ALL DIAGNOSTIC IMAGES REQUIRED HAD ALREADY BEEN OBTAINED SO THE PROCEDURE WAS COMPLETED. ALL WIRES AND SHEATHS WERE REMOVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8028178 ↗
• InjuryJul 24, 2018Material Separation; Detachment of Device or Device Component; Detachment of Device or Device Component

  A TRAILBLAZER DEVICE WAS USED WITH A 5F NON-MEDTRONIC SHEATH AND 0.36 GUIDEWIRE DURING TREATMENT OF A CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S DISTAL LEFT COMMON ILIAC ARTERY. A STEEP BIFURCATION WITH MODERATE TORTUOSITY AND CALCIFICATION ARE REPORTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. PRE-DILATION WAS NOT CARRIED OUT. IT IS REPORTED THE TRAILBLAZER SEPARATED LEAVING ONLY THE SECTION WITH THE 3-MARKER BAND. A NON-MEDTRONIC SNARE DEVICE WAS USED TO RETRIEVE SEPARATED PIECE. THE PHYSICIAN BELIEVES THE TRAILBLAZER WAS CAUGHT ON A PLAQUE AT THE BIFURCATION. THE PATIENT WILL BE BROUGHT BACK AT ANOTHER DATE TO HAVE BYPASS OF THE LESION WHICH HE WAS TRYING TO TREAT ENDOVASCULARLY. PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Code Available; Patient Problem/Medical Problem

  MAUDE report 7713289 ↗
• InjuryMar 22, 2018Detachment of Device or Device Component; Device Operates Differently Than Expected; Material Deformation; Detachment of Device or Device Component; Device Operates Differently Than Expected; Material Deformation

  IT IS REPORTED THAT WHILE USING THE TRAILBLAZER CATHETER FOR AN UNKNOWN PROCEDURE, AN INTRA-ARTERIAL RUPTURE OF THE PROBE OCCURED. THIS LEAD TO THE PROCEDURE BEING ABANDONED PLUS INTERVENTION WAS REQUIRED TO RETRIEVE THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7361039 ↗
• InjuryOct 27, 2017Detachment Of Device Component; Detachment Of Device Component

  THE PHYSICIAN USED A TRAILBLAZER SUPPORT CATHETER TO TREAT A SEVERELY CALCIFIED LESION HAVING A CHRONIC TOTAL OCCLUSION (CTO), IN THE SUPERFICIAL FEMORAL ARTERY. THE ARTERY DIAMETER WAS REPORTED TO BE 6MM AND A LESION LENGTH OF 200MM. IT WAS REPORTED THE PHYSICIAN CROSSED THE LESION WITH THE TRAILBLAZER CATHETER, BUT ENCOUNTERED DIFFICULTY REMOVING THE CATHETER. THE CATHETER BROKE, LEAVING 3 RADIO-OPAQUE MARKERS IN THE SFA. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER, AND THE LESION WAS BALLOONED AND STENTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6984445 ↗
• InjurySep 29, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS ATTEMPTING TO USE A TRAILBLAZER SUPPORT CATHETER TO TREAT A LESION IN THE SFA. THE ARTERY HAD A DIAMETER OF 6-7 MM WITH LITTLE TORTUOSITY. NO ABNORMALITIES WERE REPORTED IN RELATION TO THE PATIENT¿S ANATOMY. THE DEVICE WAS PREPPED AS PER THE IFU. THE THUMB SCREW/ LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO THE PROCEDURE. A 6 FR SHEATH AND 0.035" GUIDEWIRE WAS USED IN THE PROCEDURE, NO EMBOLIC PROTECTION WAS USED. THE VESSEL WAS NOT PRE-DILATED. THE PHYSICIAN WAS MET WITH RESISTANCE DURING ADVANCEMENT BUT NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT THE CATHETER GOT CAUGHT IN THE EXTERNAL/ COMMON ILIAC ARTERY AND WAS UNABLE TO CROSS THE LESION. THE CATHETER HAD PASSED THROUGH A PREVIOUSLY DEPLOYED UNKNOWN SELF-EXPANDING STENT. THE TIP OF THE TRAILBLAZER DETACHED AND IT HAD TO BE RETRIEVED USING A GOOSENECK SNARE. THE PROCEDURE WAS COMPLETED USING A 5 FR CATHETER AND A NEW TRAILBLAZER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6905087 ↗
• MalfunctionJul 27, 2017Break; Break

  PHYSICIAN INTENDED TO USE A TRAILBLAZER SUPPORT CATHETER FOR AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE OF THE LEFT INTERNAL ILIAC ARTERY. DEVICE IFU WAS FOLLOWED. THE PHYSICIAN WAS TRYING TO ACCESS TO THE INTERNAL ILIAC ARTERY USING A NON-MEDTRONIC 0.035" GUIDEWIRE BUT THE ANATOMY WAS TORTUOUS SO THEY INSERTED THE TRAILBLAZER TO GAIN EXTRA SUPPORT. HOWEVER, THE CATHETER SNAPPED AS IT WAS BEING ADVANCED. IT IS BELIEVED IT SNAPPED INTO TWO SEGMENTS. THE CATHETER SEGMENTS WERE REPORTED TO BE STUCK ON THE GUIDEWIRE. ALL SEGMENTS WERE RETRIEVED AS THE PHYSICIAN MANAGED TO PULL THE WIRE AND THE CATHETER OUT. THE PHYSICIAN MANAGED TO GAIN ACCESS FOLLOWING THIS AND CONTINUE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6746687 ↗
• MalfunctionMay 18, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  SURGEON WAS USING A TRAILBLAZER DEVICE FOR TREATMENT IN THE FEMORAL ARTERY. DURING RETRIEVAL OF THE LEAD ON THE GUIDE (ADVANTAGE TERUMO), A PART OF THE LEAD WAS DETACHED (ONLY 1 MARKER INSTEAD OF 3 - 5CM OF LEAD STAYED ATTACHED TO THE GUIDE IN THE FEMORAL ARTERY). THE PROCEDURE WAS CONTINUED. THE DETACHED PIECE WAS NOT LOCATED, POSSIBLY STUCK IN STENTS. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6574680 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092299. One submission often covers many models, so check the product and lot details in each record.

• Z-0497-2010 · Nov 6, 2009 · Terminated
  TrailBlazer Support Catheter, ev3 inc, 4600 Nathan Lane North, Plymouth, MN 55442-2920, Rx Only, Sterile EO. US Model Numbers: SC-014-135, SC-018-090, SC-035-065, SC-035-135, SC-