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

Model Number	H74939171041570
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 10dec2025.It was reported that ballon failure to inflate occurred.The target lesion was located in the left arteriovenous fistula.A 4.0 x 150, 75 cm mustang balloon catheter was advanced for dilation.However, during the procedure, the balloon failed to fully inflate to 4 mm due to significant vessel stenosis.The physician then opted to use an athletis high-pressure balloon catheter.The procedure was completed with a different device.There were no patient complications as a result of this event.However, returned device analysis revealed a balloon pinhole.
Additional Manufacturer Narrative
D2b: pro code: (product code): fge, lit g4: premarket / 510(k): k103751, k110122, k141521.The mustang device was returned for analysis.A visual inspection revealed that the balloon was not folded, indicating that the device had been exposed to positive pressure.A leak test was performed, during which the balloon was inflated to its rated burst pressure.A pinhole leak was noted on the distal balloon cone, approximately 8 mm proximal to the distal tip.No issues were observed with the tip of the device, and the marker bands showed no issues upon visual examination.Both visual and tactile inspections of the shaft revealed no kinks or damage.

• 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: 23892284
• Report Number: 2124215-2025-93052
• Device Sequence Number: 12091893
• Product Code: FGE
• UDI-Device Identifier: 08714729794462
• UDI-Public: (01)08714729794462(17)280520(10)36569889
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K103751
• 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): 12/25/2025

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: H74939171041570
• Device Catalogue Number: H74939171041570
• Device Lot Number: 0036569889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 12/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2025
• 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: 74 YR
• Patient Sex: Male