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

Model Number	H74939171040870
Medical Device Problem Codes	Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.Visual examination revealed that the balloon was not folded, indicating that it had been subjected to positive pressure.A complete circumferential tear of the balloon was identified approximately 70 mm distal to the proximal marker band.The distal portion of the balloon material was observed to be displaced distally toward the tip of the device.Due to the extent of the balloon damage, an inflation test could not be performed.Visual inspection showed no damage to the distal tip of the device.Visual and tactile examination indicated elongation of the shaft.Both proximal and distal marker bands were present and intact on the shaft, with no observed damage.
Event or Problem Description
Reportable based o the device analysis completed on 23dec2026.It was reported that failure to inflate occurred.The stenosed target lesion was located in the severe arteriovenous fistula.A 4.0 x 80, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the catheter failed to fully expand at 23 atmosphere.The procedure was completed using with a different device.There were no patient complications reported as a result of this event.However, returned device analysis revealed circumferential tear.

• 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: 24111638
• Report Number: 2124215-2026-03459
• Device Sequence Number: 14795240
• Product Code: LIT
• UDI-Device Identifier: 08714729794363
• UDI-Public: (01)08714729794363(17)280720(10)36997474
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K110122
• 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): 01/19/2026

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: H74939171040870
• Device Catalogue Number: H74939171040870
• Device Lot Number: 0036997474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 01/19/2026
• 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 Age: 51 YR
• Patient Sex: Male