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

Model Number	H74939171060810
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Leak/Splash (1354); Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located at the stenosis of the middle segment of the left superficial femoral artery.A 6.0 x 80, 135cm mustang catheter balloon was used for dilation.During the procedure, upon inflation, it was noted that the balloon was irregular in shape and failed to achieve the expected expansion effect and the contrast medium was seen leaking from the damaged part of the balloon.The device was removed and the procedure was completed with another for the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D2b: pro code (product code): fge, lit e1: initial reporter facility name: (b)(6) college.E1: initial reporter phone: (b)(6).G4: premarket / 510(k) #: k141521, k141597.
Additional Manufacturer Narrative
D2b: pro code (product code): fge, lit e1: initial reporter facility name: (b)(6).E!: initial reporter phone: (b)(6).G4: premarket / 510(k) #: k141521, k141597.Device evaluated by mfr.: mustang device was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured approximately 12mm in length and extended from a position 1mm proximal of the proximal markerband to 10mm distal of the proximal markerband.Visual examination observed no damage to the tip of the device.A visual and tactile examination found multiple shaft kinks.Both markerbands were undamaged and present on the shaft of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located at the stenosis of the middle segment of the left superficial femoral artery.A 6.0 x 80, 135cm mustang catheter balloon was used for dilation.During the procedure, upon inflation, it was noted that the balloon was irregular in shape and failed to achieve the expected expansion effect and the contrast medium was seen leaking from the damaged part of the balloon.The device was removed and the procedure was completed with another for the same device.There were no patient complications as a result of this 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23501332
• Report Number: 2124215-2025-81054
• Device Sequence Number: 8965853
• Product Code: FGE
• UDI-Device Identifier: 08714729793793
• UDI-Public: (01)08714729793793(17)270820(10)34670596
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141521
• 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,Followup
• Report Date (Section B): 12/30/2025

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: H74939171060810
• Device Catalogue Number: H74939171060810
• Device Lot Number: 0034670596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2024
• 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: Male
• Patient Weight: 65 KG