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

Model Number	H74939171050470
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on the device analysis completed on 4mar2026.It was reported that balloon failure to inflate occurred.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified lesion.A 5.0 x 40, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon did not inflate properly.The procedure was then complete using with a different device.There were no patient complication as a result of this event.However, completed device analysis revealed a longitudinal tear.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the returned device was received for evaluation.Visual inspection identified that the balloon was not in a folded configuration, indicating that it had been subjected to positive pressure.A longitudinal tear was observed in the balloon material, measuring approximately 35 mm in length and extending from approximately 2 mm distal to the proximal marker band to 4 mm proximal to the distal marker band.Due to the presence of this tear, the investigator was unable to inflate the balloon.Further examination revealed no damage to the device tip.Visual and tactile assessment of the shaft identified no kinks or other 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 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 balloon catheter 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 adverse event related to 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: 24737246
• Report Number: 2124215-2026-17415
• Device Sequence Number: 18458930
• Product Code: LIT
• UDI-Device Identifier: 08714729793366
• UDI-Public: (01)08714729793366(17)280812(10)37196099
• 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
• Report Date (Section B): 03/30/2026

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: 0037196099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2025
• 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 Age: 78 YR
• Patient Sex: Male