MalfunctionLIT
COYOTE? ES
Received Jul 12, 2026 · Event occurred Jun 17, 2026
Report 2124215-2026-37287 · MDR key 25791286
Device
Generic name
Catheter, Angioplasty, Peripheral, Transluminal
Manufacturer
Boston Scientific CorporationModel number
H74939135254010Catalog number
H74939135254010
Lot number
0038291926
Product problems
- Material Rupture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL BELOW THE KNEE. A2.5MM X 40MM X 146CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE FIFTH INFLATION AT 6 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.