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

Model Number	H74939171061070
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and device entrapment occurred.The target lesion was located at the bifurcation site proximal to the shunt anastomosis with severe tortuosity and 90% stenosis.A 6.0 x 100, 75cm mustang balloon catheter was selected for use.Approximately seven inflations were performed at 18 atmospheres at the bifurcation site, followed by approximately ten inflations at 18 atmospheres at the anastomosis site.Four additional inflations were subsequently performed at the bifurcation; however, during the 21st and final inflation at 18 atmospheres, the balloon ruptured.Following the rupture, the device became stuck and could not be removed.An attempt was made to completely remove the system, but the device became stuck again at the approach site.The physician determined that further removal attempts could result in device separation, so the device was surgically removed.No additional patient complications were reported as a result of this event, and the patient was in good condition.

• 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: 25461004
• Report Number: 2124215-2026-30972
• Device Sequence Number: 18744521
• Product Code: LIT
• UDI-Device Identifier: 08714729793625
• UDI-Public: (01)08714729793625(17)290212(10)38592105
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141597
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939171061070
• Device Catalogue Number: H74939171061070
• Device Lot Number: 0038592105
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/08/2026
• 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: 05/14/2026
• Supplement Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male