TrailBlazer™ SC-035-135 (UDI 00821684058046)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821684058046), received between Dec 15, 2017 and Apr 8, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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. 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.

• InjuryApr 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS USING A TRAILBLAZER TO TREAT A SEVERELY CALCIFIED LESION IN THE MID LEFT COMMON ILIAC ARTERY. THE ARTERY HAD LITTLE TORTUOSITY. THE IFU WAS FOLLOWED. IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE OFF AND HAD TO BE SNARED. THE PROCEDURE WAS ABORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8491516 ↗
• InjuryMar 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN USED A TRAILBLAZER SUPPORT CATHETER WITH A 6FR SHEATH AND NON-MEDTRONIC (GLIDEWIRE) WIRE DURING TREATMENT OF A 30MM CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENTS LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). ARTERY DIAMETER IS REPORTED AS 7MM. NO TORTUOUSITY AND SEVERE CALCIFICATION ARE REPORTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED THAT A KINK WAS OBSERVED ON THE DISTAL CATHETER DURING SECOND ADVANCEMENT OF THE DEVICE. THE CATHETER WAS NOT GRIPPED AT THE DISTAL TIP. WHEN THE TRAILBLAZER WAS REMOVED FROM THE PATIENT A PIECE WAS OBSERVED TO BE REMAINING IN THE PATIENTS COMMON FEMORAL ARTERY BESIDE AND DISTAL TO THE SHEATH. A SNARE WAS USED TO REMOVE THE DETACHED PORTION. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8408078 ↗
• InjuryDec 18, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN EMPLOYED THE USE OF A TRAILBLAZER SUPPORT CATHETER DURING TREATMENT OF A SEVERELY CALCIFIED LESION IN THE MID COMMON ILIAC ARTERY. VESSEL DESCRIBED AS BEING MODERATELY TORTUOUS. LESION EXHIBITED 70% STENOSIS. IFU WAS FOLLOWED. VESSEL WAS NOT PRE-DILATED. IT WAS REPORTED THAT THE TRAILBLAZER CATHETER TIP (10CM) BROKE OFF OF A NON-MEDTRONIC 260CM GUIDEWIRE. TIP WAS RECOVERED WITH A NON-MEDTRONIC SNARE DEVICE. ALL SEGMENTS WERE RETRIEVED, NONE STUCK ON GUIDEWIRE. A NEW TRAILBLAZER CATHETER WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7124803 ↗
• InjuryDec 15, 2017Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A TRAILBLAZER SUPPORT CATHETER FOR TREATMENT OF A SEVERELY CALCIFIED PLAQUE LESION IN THE LEFT COMMON ILIAC ARTERY. VESSEL REPORTED TO BE MODERATELY TORTUOUS. LESION EXHIBITED 90% STENOSIS. IFU WAS FOLLOWED. DEVICE INSPECTED BEFORE USE. VESSEL WAS PRE-DILATED. WHILE INSERTING THE GUIDEWIRE INTO THE CATHETER, PHYSICIAN EXPERIENCED RESISTANCE WHEN IT WAS CLOSE TO THE DISTAL MARK. NO OTHER ABNORMALITIES OBSERVED. AFTER CROSSING THE LESION WITH GUIDEWIRE AND CATHETER, THE PHYSICIAN INTENDED TO REMOVE THE SUPPORTING CATHETER AND REPLACE IT WITH AN ANGIOGRAPHY CATHETER; DIFFICULTY WAS EXPERIENCED WHEN TRYING TO REMOVE THE DEVICE. CT SHOWED THE THREE RADIO-OPAQUE MARKS WERE STILL IN THE VESSEL, AND CONFIRMED FRACTURED IN THE PATIENT. PATIENT WAS REFERRED FOR EMERGENCY SURGERY. THE RETRIEVAL OF THE BROKEN CATHETER PIECE TOOK TWO HOURS, WHICH RESULTED IN THE PATIENT HAVING HEMORRHAGIC SHOCK. PROCEDURE WAS CANCELLED, AND THE PATIENT WAS SENT TO ICU. IT WAS REPORTED THAT ALL SEGMENTS OF THE TRAILBLAZER CATHETER WERE RETRIEVED. UPDATED INFORMATION RECEIVED 10 DAYS POST-PROCEDURE INDICATED THAT THE PATIENT WAS STILL IN ICU. FURTHER INFORMATION RECEIVED 8 DAYS LATER IN

  Patient problems: Device Embedded In Tissue or Plaque; Shock

  MAUDE report 7123338 ↗

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-