TrailBlazer™Angled ASC-035-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169694941), received between Nov 10, 2017 and Nov 10, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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.

• MalfunctionNov 10, 2017Device Damaged by Another Device; Device Damaged by Another Device

  PHYSICIAN INTENDED TO USE A TRAILBLAZER ANGLED CATHETER WITH A 6FR SHEATH AND NON-MEDTRONIC 0.035¿ GUIDEWIRE FOR THE TREATMENT OF A SEVERELY CALCIFIED, MODERATELY TORTUOUS PLAQUE LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY OF DIAMETER 5MM. ANATOMY ABNORMALITIES REPORTED AS LONG CHRONIC TOTAL OCCLUSION (CTO). IT WAS REPORTED THAT IFU WAS FOLLOWED DURING PREPARATION. THE VESSEL WAS PRE-DILATED. IT WAS REPORTED THAT DURING PROCEDURE, THE NON-MEDTRONIC WIRE GOT STUCK INSIDE OF THE 0.035 ANGLED TRAILBLAZER AND COULD NOT BE REMOVED. PHYSICIAN ENDED UP LOSING ACCESS AND COULD NOT RE-CROSS THE CTO. THE PHYSICIAN THEN STOPPED PROCEDURE AND TREATED PROXIMAL SFA. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7023099 ↗