inforMED
MalfunctionLIT

MUSTANG?

Received Jul 20, 2026 · Event occurred Jun 29, 2026

Report 2124215-2026-38714 · MDR key 25874038

Device

Generic name

Stents, Drains And Dilators For The Biliary Ducts

Model number

H74939171060440

Catalog number

H74939171060440

Lot number

0038930611

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 MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT FOREARM VESSEL. A 6.0 X 40, 40CM MUSTANG BALLOON CATHETER WAS ADVANCED TO THE LESION FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 24 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED WITH A PINHOLE LEAK. THE BALLOON WAS REMOVED WITHOUT DIFFICULTY USING THE NORMAL METHOD, AND THE PROCEDURE WAS COMPLETED USING ANOTHER MUSTANG BALLOON CATHETER OF THE SAME MODEL. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.