TrailBlazer™ Angled ASC-014-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000104658), received between Dec 3, 2019 and Dec 3, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2019Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  PHYSICIAN USED AN ANGLED TRAILBLAZER DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S PROXIMAL ANTERIOR TIBIAL ARTERY (OF DIAMETER 3.0-3.5MM). MODERATE VESSEL CALCIFICATION AND SLIGHT TORTUOSITY ARE REPORTED. IFU WAS FOLLOWED. IT IS REPORTED THAT WHEN TRYING TO TORQUE THE CATHETER TO GET INTO THE ANTERIOR TIBIAL, THE CATHETER BROKE OFF. DUE TO THE LOCATION OF THE BREAK, THE PHYSICIAN WAS ABLE TO RETRIEVE THE CATHETER FROM THE SHEATH. A DIFFERENT 0.035¿ DIAGNOSTIC CATHETER WAS THEN USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9400794 ↗