MUSTANG?
Received Jul 13, 2026 · Event occurred Jun 19, 2026
Report 2124215-2026-37347 · MDR key 25796580
Device
Generic name
Stents, Drains And Dilators For The Biliary Ducts
Manufacturer
Boston Scientific CorporationModel number
H74939171061070Catalog number
H74939171061070
Lot number
0038254463
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 99% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILIAC VESSEL. A 6.0 X 100, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR LESION DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE BALLOON WAS REMOVED WITHOUT DIFFICULTY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.