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	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous venous side artery.A 6.0 x 100, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured after the first inflation.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.
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous venous side artery.A 6.0 x 100, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured after the first inflation.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
With the available information, boston scientific concludes: device evaluation by manufacturer: visual examination revealed that the balloon was not folded, indicating that it had been exposed to positive pressure.A longitudinal tear was observed in the balloon material, measuring approximately 14 mm in length and extending from approximately 5 mm proximal to the proximal marker band to 7 mm distal to the proximal marker band.Examination of the device tip showed no evidence of damage.Visual and tactile inspection of the shaft identified no kinks or damage.Both marker bands were present and intact on the shaft of the device.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.Investigation conclusion: based on a thorough review of the reported complaint, the most probable cause of the event is attributed to an adverse event related to the patient condition.Product analysis did not identify any device damage, malfunction, or abnormality prior to the attempted inflation of the balloon.The issue occurred when the balloon was inflated at a lesion site described as 75% stenosed and moderately tortuous.These findings suggest that the patient anatomy and lesion characteristics most likely contributed to the occurrence of the balloon tear.Risk review: a risk review was completed and confirmed that the event of 5030: balloon- 1827: material rupture was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24021652
• Report Number: 2124215-2026-01547
• Device Sequence Number: 10591003
• Product Code: LIT
• UDI-Device Identifier: 08714729793625
• UDI-Public: (01)08714729793625(17)280528(10)36629747
• 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): 03/11/2026

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: 0036629747
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/11/2026
• Date Device Manufactured: 05/29/2025
• 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