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
Manufacturer
Boston Scientific CorporationModel number
H74939171060440Catalog 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.