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

Model Number	H74939171081070
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the arteriovenous fistula.A 8.0 x 100, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured.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 analysis.Visual examination showed that the balloon was not folded, indicating that the device had been subjected to positive pressure.A leak test was performed, during which the balloon was inflated to its rated burst pressure of 20 atmospheres using deionized water and digital timer (g24610) for 30 seconds, with no issues observed.A vacuum was subsequently applied.The inflation device was verified at 20 atmospheres before and after testing using a calibrated pressure gauge.The inflation to rated burst pressure was repeated three times, with no leaks or pressure drops noted.No issues were identified with balloon inflation or the balloon material.As per specification.The rated burst pressure for this device is 20 atmospheres.No abnormalities were observed at the device tip.Visual inspection of the marker bands identified no issues.Additionally, visual and tactile examination of the shaft revealed no kinks or 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 risk review performed for the mustang device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefits for the product.Investigation conclusion: based on a thorough review of the reported complaint, the most probable cause for this complaint was no problem detected.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the arteriovenous fistula.A 8.0 x 100, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured.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: 24262109
• Report Number: 2124215-2026-06488
• Device Sequence Number: 15846691
• Product Code: LIT
• UDI-Device Identifier: 08714729793700
• UDI-Public: (01)08714729793700(17)260131(10)30955101
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 04/09/2026

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 Expiration Date: 01/31/2026
• Device Model Number: H74939171081070
• Device Catalogue Number: H74939171081070
• Device Lot Number: 0030955101
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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: 70 YR
• Patient Sex: Male