MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG?; stents, drains and dilators for the biliary ducts

Model Number	H74939171060810
Medical Device Problem Codes	Nonstandard Device (1420); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code: (product code): fge, lit.E1: initial reporter phone: (b)(6).G4: premarket / 510(k): k141521, k141597.
Event or Problem Description
It was reported that a balloon rupture occurred during a transjugular intrahepatic portosystemic shunt (tips) procedure.The target lesion was located within a non-tortuous, non-calcified hepatic vessel.During the procedure, a 5.0 mm x 80 mm, 135 cm mustang balloon catheter was advanced to the target site for vessel dilatation.During inflation, the balloon ruptured when the pressure reached 14 atmospheres.The device was removed, and the procedure was completed.The event was not attributed to challenging patient anatomy, underlying comorbidities, disease progression, or other procedural factors.No patient complications reported as a result of the event, and the patient remained stable post-procedure.

• Brand Name: MUSTANG?
• Common Device Name: stents, drains and dilators for the biliary ducts
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 25729347
• Report Number: 2124215-2026-36243
• Device Sequence Number: 16090441
• Product Code: FGE
• UDI-Device Identifier: 08714729793793
• UDI-Public: (01)08714729793793(17)280812(10)37196188
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939171060810
• Device Catalogue Number: H74939171060810
• Device Lot Number: 0037196188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Supplement Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 07/07/2026
• Supplement Report FDA Received Date: 08/07/2026
• Date Device Manufactured: 08/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male