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

Model Number	H74939171040270
Medical Device Problem Codes	Fluid/Blood Leak (1250); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon leaked from a hole.The target lesion was located in a mildly tortuous and moderately calcified left renal artery.A 4.0 x 20, 75cm mustang balloon was selected for use in a stenting procedure in the left renal artery and the left iliac artery.During the procedure, there was resistance when inserting the catheter with the wire.After the balloon catheter was inserted into the renal artery and the balloon was filled, it immediately became apparent that the balloon had a hole and contrast medium was leaking out.The balloon could not be expanded further.The procedure was completed with an alternate device.There were no patient complications as a result of this event, and the patient fully recovered.
Event or Problem Description
It was reported that the balloon leaked from a hole.The target lesion was located in a mildly tortuous and moderately calcified left renal artery.A 4.0 x 20, 75cm mustang balloon was selected for use in a stenting procedure in the left renal artery and the left iliac artery.During the procedure, there was resistance when inserting the catheter with the wire.After the balloon catheter was inserted into the renal artery and the balloon was filled, it immediately became apparent that the balloon had a hole and contrast medium was leaking out.The balloon could not be expanded further.The procedure was completed with an alternate device.There were no patient complications as a result of this event, and the patient fully recovered.
Additional Manufacturer Narrative
Device evaluation by manufacturer: a mustang device was received for analysis.As per the mustang specification, the catheter is compatible with a 0.035in (0.89 mm) guidewire.The investigator loaded a boston scientific 0.035in guidewire through the mustang device and removed it with no resistance encountered.The guidewire used by the customer was not returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The rated burst pressure for this device is 24 atmospheres as per mustang specification.The returned device was attached to an encore inflation unit.Positive pressure was applied when di water was observed to be leaking from a balloon pinhole located approximately 1mm distal from the distal markerband.A visual and tactile examination identified no issues with the shaft of 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: 23751424
• Report Number: 2124215-2025-85575
• Device Sequence Number: 15848861
• Product Code: LIT
• UDI-Device Identifier: 08714729793496
• UDI-Public: (01)08714729793496(17)280722(10)37034939
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: H74939171040270
• Device Catalogue Number: H74939171040270
• Device Lot Number: 0037034939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2025
• 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 Sex: Unknown