MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG?; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	H74939171061070
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0 x 100, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured after the first inflation at 16 atmospheres.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Investigation results: the device was returned for evaluation.Visual inspection confirmed that the balloon was not in a folded configuration, indicating that it had been subjected to positive pressure.A longitudinal tear was identified in the balloon material, measuring approximately 17 mm in length and extending from approximately 3 mm proximal to the proximal marker band to 12 mm distal to the distal marker band.Examination of the device tip revealed no evidence of damage.Additionally, visual and tactile assessment of the shaft identified no kinks or abnormalities.Both marker bands were present, intact, and showed no signs of damage.Device history records (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a review of the mustang device confirmed that the reported event is a known event defined in the products risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to procedure.
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0 x 100, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured after the first inflation at 16 atmospheres.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications 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 ; 7634941632
• MDR Report Key: 24273566
• Report Number: 2124215-2026-06487
• Device Sequence Number: 10722763
• Product Code: LIT
• UDI-Device Identifier: 08714729793625
• UDI-Public: (01)08714729793625(17)280708(10)36923741
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141597
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 04/03/2026

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: H74939171061070
• Device Catalogue Number: H74939171061070
• Device Lot Number: 0036923741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• 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 Sex: Unknown