COYOTE?
Received Jul 5, 2026 · Event occurred Jun 11, 2026
Report 2124215-2026-35900 · MDR key 25712939
Device
Generic name
Catheter, Percutaneous
Manufacturer
Boston Scientific CorporationModel number
H74939185202210Catalog number
H74939185202210
Lot number
0037470767
Product problems
- Material Rupture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
G4: PREMARKET / 510(K): K111295, K162350.
Description of Event or Problem
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED VESSEL BELOW THE KNEE. A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INITIAL INFLATION AT 3 ATMOSPHERES FOR A FEW SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.