COYOTE? ES
Received Jul 6, 2026 · Event occurred Jun 10, 2026
Report 2124215-2026-35922 · MDR key 25715422
Device
Generic name
Catheter, Angioplasty, Peripheral, Transluminal
Manufacturer
Boston Scientific CorporationModel number
H74939135304010Catalog number
H74939135304010
Lot number
0038272083
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 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY. A 3MM X 40MM X 146CM COYOTE ES BALLOON WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT DISTAL TIP OF THE BALLOON RUPTURED UPON UNPACKING. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM USING THE NORMAL METHOD, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.
Additional Manufacturer Narrative
BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED.