MUSTANG?
Received Jul 7, 2026 · Event occurred Jun 10, 2026
Report 2124215-2026-36240 · MDR key 25728905
Device
Generic name
Stents, Drains And Dilators For The Biliary Ducts
Manufacturer
Boston Scientific CorporationModel number
H74939171090870Catalog number
H74939171090870
Lot number
0038254628
Product problems
- Material Rupture
Patient
65 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE BALLOON BURST DURING USE. DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE TO TREAT AN ARTERIOVENOUS FISTULA (AVF), A MUSTANG 9.0 X 80, 75CM BALLOON CATHETER WAS INFLATED INSIDE THE PATIENT. DURING INFLATION, THE BALLOON BURST. THE DEVICE WAS REPLACED WITH ANOTHER MUSTANG BALLOON CATHETER OF THE SAME SIZE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT REMAINED STABLE AS A RESULT OF THIS EVENT.