MUSTANG?
Received Jul 12, 2026 · Event occurred Jun 17, 2026
Report 2124215-2026-37288 · MDR key 25791357
Device
Generic name
Stents, Drains And Dilators For The Biliary Ducts
Manufacturer
Boston Scientific CorporationModel number
H74939171060470Catalog number
H74939171060470
Lot number
0038592039
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. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.
Description of Event or Problem
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 6.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT 6 ATMOSPHERES. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.