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

Model Number	H74939171051070
Medical Device Problem Codes	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	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified vessel in the left forearm.A 5.0 x 100, 75cm mustang balloon was advanced for dilation.However, during the first inflation at 15 atmospheres for 10 seconds, the balloon ruptured.The device was removed 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 in good condition post-procedure.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.D2b - pro code (product code): fge, lit.(b)(6).G4 - premarket / 510(k) #: k141521, k141597.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.D2b - pro code (product code): fge, lit.E1 - initial reporter city: (b)(6).G4 - premarket / 510(k) #: k141521, k141597.Investigation results: device evaluated by mfr: the mustang device was returned to our post market quality assurance laboratory.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured approximately 55mm in length and extended from a position of approximately 2mm distal of the proximal markerband to 57mm distal of the proximal markerband.A visual examination observed no damage to the tip of the device.A visual and tactile examination found a shaft kink approximately 320mm proximal from the distal tip.Both markerbands were undamaged and present on the shaft 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 that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review performed for the mustang device confirmed that the event of balloon material rupture is 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: updated: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to patient condition.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified vessel in the left forearm.A 5.0 x 100, 75cm mustang balloon was advanced for dilation.However, during the first inflation at 15 atmospheres for 10 seconds, the balloon ruptured.The device was removed 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 in good condition 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: 24176200
• Report Number: 2124215-2026-04374
• Device Sequence Number: 21227138
• Product Code: FGE
• UDI-Device Identifier: 08714729793892
• UDI-Public: (01)08714729793892(17)280604(10)36682503
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/02/2026

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: H74939171051070
• Device Catalogue Number: H74939171051070
• Device Lot Number: 0036682503
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE - SURF; GUIDEWIRE - SURF; INFLATION DEVICE - GM30; INFLATION DEVICE - GM30; INTRODUCER SHEATH - NIPRO; INTRODUCER SHEATH - NIPRO
• Patient Sex: Unknown