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

Model Number	H74939171080410
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 31oct2025.It was reported that balloon leak occurred.The patient was presented with thoracic aortic aneurysm.The 70% stenosed target lesion was located in the mildly tortuous and moderately calcified thoracic aorta and subclavian artery.An 8.0 x 40, 135cm mustang balloon catheter was advanced for dilation.The balloon inflated twice at 10 kilopascals (kpa), however, under balloon angiography, it was confirmed that there was an obvious manifestation of contrast agent leakage at the tip of the balloon.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed balloon tear.
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit e1 - initial reporter phone: (b)(6).G4 - premarket / 510(k): k141521, k141597.Device evaluated by mfr: the mustang device was returned for evaluation.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 37mm in length and extended from a position 10mm distal of the proximal markerband to 12mm distal of the distal markerband.A visual examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.No other issues were identified with the device.
Event or Problem Description
Reportable based on device analysis completed on 31oct2025.It was reported that balloon leak occurred.The patient was presented with thoracic aortic aneurysm.The 70% stenosed target lesion was located in the mildly tortuous and moderately calcified thoracic aorta and subclavian artery.An 8.0 x 40, 135cm mustang balloon catheter was advanced for dilation.The balloon inflated twice at 10 kilopascals (kpa), however, under balloon angiography, it was confirmed that there was an obvious manifestation of contrast agent leakage at the tip of the balloon.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed balloon tear.
Additional Manufacturer Narrative
A1 - patient identifier: added a1 - age at time of event: corrected.D2b - pro code (product code): fge, lit e1 - initial reporter phone: (b)(6) g4 - premarket / 510(k): k141521, k141597.Device evaluated by mfr: the mustang device was returned for evaluation.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 37mm in length and extended from a position 10mm distal of the proximal markerband to 12mm distal of the distal markerband.A visual examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.No other issues were identified with the device.

• 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: 23618850
• Report Number: 2124215-2025-85516
• Device Sequence Number: 15963808
• Product Code: FGE
• UDI-Device Identifier: 08714729793663
• UDI-Public: (01)08714729793663(17)270619(10)34270686
• 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): 12/11/2025

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: H74939171080410
• Device Catalogue Number: H74939171080410
• Device Lot Number: 0034270686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2024
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 75 KG