MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG?; stents, drains and dilators for the biliary ducts

Model Number	H74939171062070
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6)2026.It was reported that balloon advancing issue occurred.The 50-60% stenosed target lesion was located in the severely tortuous and mildly calcified arteriovenous fistula.A 6.0 x 200, 75cm mustang balloon catheter was advanced for dilation.During the procedure, the balloon was fully deflated prior to advancement.However, significant resistance was encountered while advancing the catheter through the sheath.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient's condition post-procedure was stable.However, device analysis revealed a complete circumferential tear located at approximately 53mm distal of the proximal sleeve.A separation of the shaft was located at approximately at the same location of the complete circumferential tear, and the proximal markerband was found to be damaged.
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.E1 - initial reporter phone: (b)(6).G4 - premarket / 510(k) #: k103751, k110122, k141521.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 tightly folded indicating that it had been subjected to positive pressure.A complete circumferential tear was identified, located at approximately 53mm distal of the proximal sleeve.The distal section of balloon was not returned.No other issues were found with the balloon material.A visual and tactile examination found stretching to the shaft in multiple locations.A separation of the shaft was located at approximately at the same location of the complete circumferential tear.The distal section of shaft including a section of balloon material, the distal markerband and tip were not returned.The tip of the device was not returned for analysis with the distal section of the device.The proximal markerband was found to be damaged.Distal markerband was not returned for analysis with the distal section of the device.This concludes the product analysis.Device history record (dhr) review: the device history record review confirmed that the device met all material, assembly, and performance specifications prior to distribution.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, boston scientific has assigned an investigation conclusion code of unintended use or error caused or contributed to 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 ; +1(612)875-7234
• MDR Report Key: 50836563
• Report Number: 2124215-2026-50118
• Device Sequence Number: 10301818
• Product Code: FGE
• UDI-Device Identifier: 08714729794509
• UDI-Public: (01)08714729794509(17)280816(10)37226683
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K103751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: H74939171062070
• Device Catalogue Number: H74939171062070
• Device Lot Number: 0037226683
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2025
• 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: 73 YR
• Patient Sex: Male