COYOTE?
Received Jul 13, 2026 · Event occurred Jun 24, 2026
Report 2124215-2026-37349 · MDR key 25796559
Device
Generic name
Catheter, Percutaneous
Manufacturer
Boston Scientific CorporationModel number
H74939185202210Catalog number
H74939185202210
Lot number
0039127424
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 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL VESSEL. A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR LESION DILATATION. HOWEVER, AFTER FIVE INFLATIONS AT 14 ATMOSPHERES FOR SEVERAL SECONDS EACH, THE BALLOON RUPTURED LONGITUDINALLY DURING THE FIFTH INFLATION. THE BALLOON WAS REMOVED WITHOUT DIFFICULTY. THE PROCEDURE WAS COMPLETED USING A DIFFERENT MODEL BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE AS A RESULT OF THIS EVENT.