MUSTANG?
Received Jul 15, 2026 · Event occurred Jun 19, 2026
Report 2124215-2026-37942 · MDR key 25825826
Device
Generic name
Stents, Drains And Dilators For The Biliary Ducts
Manufacturer
Boston Scientific CorporationModel number
H74939171060410Catalog number
H74939171060410
Lot number
0036783495
Product problems
- Material Rupture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D2B - PRO CODE (PRODUCT CODE): FGE, LIT. G4 - PREMARKET / 510(K): K141521, K141597.
Description of Event or Problem
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE SEVERELY CALCIFIED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 6.0 X 40, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED INTO THE LESION FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER HIGH-PRESSURE BALLOON FOLLOWED BY STENT PLACEMENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.