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

Model Number	H74939171100410
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.(b)(6) hospital, (b)(6).E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).G4 - premarket / 510(k) #: k141521, k141597.B5: describe event or problem: updated.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to patient condition.
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the subclavian artery.A 10.0 x 40, 135cm mustang balloon was advanced for dilation.However, it was noted that the balloon ruptured when the pressure reached 12 atmospheres during the procedure.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.It was further reported that the target lesion was moderately tortuous and moderately calcified.The balloon completely removed from the patient's body via guiding sheath after air was removed from the balloon.

• 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(612)875-7234
• MDR Report Key: 50644953
• Report Number: 2124215-2026-47517
• Device Sequence Number: 13276536
• Product Code: FGE
• UDI-Device Identifier: 08714729793823
• UDI-Public: (01)08714729793823(17)280603(10)36672101
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: H74939171100410
• Device Catalogue Number: H74939171100410
• Device Lot Number: 0036672101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/07/2026
• Supplement Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 06/04/2025
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 165 LB