Coyote™ ES H74939135253010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729767213), received between Jul 11, 2019 and Jul 11, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Entrapment of 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 18, 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.

• MalfunctionJul 11, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. AFTER A NON-BSC GUIDEWIRE CROSSED THE LESION, A 2.5MM X 30MM X 145CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING ADVANCEMENT OF THE DEVICE, SLIGHT RESISTANCE WAS FELT. AFTER DILATATION WAS PERFORMED, THE BALLOON COULD NOT BE REMOVED FROM THE GUIDE CATHETER WITH THE GUIDE WIRE BEING REMAINED INSIDE THE BODY. THE BALLOON CATHETER AND THE GUIDE WIRE WERE THEN REMOVED TOGETHER OUTSIDE THE PATIENT'S BODY. WHEN TRIED TO REMOVED THE BALLOON FROM THE GUIDE WIRE, SEVERE RESISTANCE WAS FELT BUT EVENTUALLY THE BALLOON CATHETER WAS ABLE TO REMOVE. FINALLY, AFTER PLACING THE SAME GUIDE WIRE IN THE LESION, AN 8MM X 29MM CAROTID WALL STENT ADVANCED AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8781026 ↗