Coyote? ES
Received Jul 28, 2026 · Event occurred Jul 7, 2026
Report 2124215-2026-40262 · MDR key 50053791
Device
Generic name
Catheter, Angioplasty, Peripheral, Transluminal
Manufacturer
Boston Scientific CorporationModel number
H74939135152010Catalog number
H74939135152010
Lot number
0039150873
Product problems
- Material Rupture
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified right superficial femoral artery. A 1.5mm x 20mm x 143cm Coyote ES balloon catheter was advanced for dilation. During inflation, the balloon ruptured. The device was removed using normal method without issue and the procedure was completed with a different device. There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Investigation results:Investigation conclusion: Based on a thorough review of the reported complaint, Boston Scientific has assigned an investigation conclusion code of Adverse Event Related to Patient Condition.