inforMED
MalfunctionLIT

COYOTE?

Received Jul 13, 2026 · Event occurred Jun 24, 2026

Report 2124215-2026-37349 · MDR key 25796559

Device

Generic name

Catheter, Percutaneous

Model number

H74939185202210

Catalog 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.