COYOTE? ES
Received Jul 9, 2026 · Event occurred Jun 18, 2026
Report 2124215-2026-36994 · MDR key 25773166
Device
Generic name
Catheter, Angioplasty, Peripheral, Transluminal
Manufacturer
Boston Scientific CorporationModel number
H74939134152010Catalog number
H74939134152010
Lot number
0038030742
Product problems
- Material Rupture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. A 1.5MM X 20MM X 142CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. FOLLOWING SUCCESSFUL GUIDEWIRE CROSSING, A BALLOON CATHETER WAS ADVANCED FOR LESION DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE RUPTURED BALLOON WAS REPLACED WITH ANOTHER OF THE SAME MODEL AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.