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

Model Number	H74939171050470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified arm arteriovenous shunt.A 5.0 x 40, 75cm mustang balloon was advanced for dilation.However, during the first inflation, the balloon burst before it was inflated to the nominal burst pressure.The device was removed slowly and carefully, and 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.
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit e1 - initial reporter address 1: (b)(6) g4 - premarket / 510(k) #: k141521, k141597.
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.(b)(6).G4 - premarket / 510(k) #: k141521, k141597.Device analysis findings: upon receipt at our post market quality assurance laboratory, a visual examination identified that the balloon was not folded, which indicates that the device was subjected to positive pressure.A leak test was carried out, and the balloon was inflated to its rated burst pressure for 30 seconds using deionized water and digital timer without issue.A vacuum was then applied.The inflation device was verified at 24 atmospheres, before and after use with calibrated pressure gauge.This inflation to rate of burst pressure was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.As per specification, the rated burst pressure for this device is 24 atmospheres.A visual and tactile examination found no kinks or damage to the shaft, tip, and markerbands of the device.This concludes the product analysis.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which 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 product's 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 no problem detected.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified arm arteriovenous shunt.A 5.0 x 40, 75cm mustang balloon was advanced for dilation.However, during the first inflation, the balloon burst before it was inflated to the nominal burst pressure.The device was removed slowly and carefully, and 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.

• 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: 24445063
• Report Number: 2124215-2026-10505
• Device Sequence Number: 18705779
• Product Code: FGE
• UDI-Device Identifier: 08714729793366
• UDI-Public: (01)08714729793366(17)280720(10)36997540
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K141521
• 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): 04/10/2026

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: H74939171050470
• Device Catalogue Number: H74939171050470
• Device Lot Number: 0036997540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2025
• 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