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

Model Number	H74939171072070
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.G4 - premarket / 510(k) #: k103751, k110122, k141521.
Event or Problem Description
It was reported that balloon rupture occurred.A 7.0 x 200, 75cm mustang was advanced for dilation.However, during the procedure, it was noted that the balloon ruptured.There were no patient compilations as a result of this event,.

• 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: 25351186
• Report Number: 2124215-2026-29221
• Device Sequence Number: 18723762
• Product Code: FGE
• UDI-Device Identifier: 08714729794189
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K103751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2026

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: H74939171072070
• Device Catalogue Number: H74939171072070
• Device Lot Number: 0038532638
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/27/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 06/01/2026
• Supplement Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2026
• 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 Sex: Unknown