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

Model Number	H74939171050470
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 11jul2025.It was reported that balloon failed to inflate and leak occurred.The target lesion was located in the arteriovenous fistula (avf).A 5.0 x 40, 75cm mustang was selected for procedure.During the procedure, it was noted that contrast media was leaking from the catheter tip and the balloon was defective as it could not expand.The procedure was completed with another of same device.There were no patient complications as a result of this event.However, returned device analysis revealed a balloon tear.
Additional Manufacturer Narrative
D2b: pro code (product code): fge, lit.G4: premarket / 510(k) #: k141521, k141597.Device evaluated by mfr: the mustang device was returned for further analysis.Upon visual inspection, it was noted that the balloon was not folded, suggesting that it had been subjected to positive pressure.A longitudinal tear in the balloon material was identified, measuring 21mm in length.This tear extended from approximately 1mm proximal to the distal marker band to 22mm proximal of the same marker band.A detailed visual examination revealed no damage to the tip of the device.Additionally, a combined visual and tactile assessment of the shaft showed no signs of kinking or other 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: 22722654
• Report Number: 2124215-2025-54404
• Device Sequence Number: 8878493
• Product Code: FGE
• UDI-Device Identifier: 08714729793366
• UDI-Public: (01)08714729793366(17)280202(10)35762903
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 08/05/2025

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: H74939171050470
• Device Catalogue Number: H74939171050470
• Device Lot Number: 0035762903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2025
• 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: 67 YR
• Patient Sex: Female