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

Model Number	H74939171090470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.G4 - premarket / 510(k) #: k141521, k141597.
Event or Problem Description
It was reported that balloon rupture occurred.The 30-40% stenosed target lesion was located in the non-tortuous and mildly calcified vessel.A 9.0 x 40, 75cm mustang balloon was selected for leg angioplasty.However, during the first inflation, when the balloon was pressurized to 4 kilopascals for 5 seconds, the balloon ruptured.The device was removed slowly, and no device fragments were left inside the patient's body.The procedure was completed with an alternate device.There were no patient complications as a result of this event, and the patient was in good condition post-procedure.
Additional Manufacturer Narrative
Correction to e1: initial reporter email from (b)(6) to (b)(6).Investigation results: device evaluated by mfr: the mustang device was returned to our post market quality assurance laboratory.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A balloon longitudinal tear was identified beginning approximately 11mm distal of the distal markerband and extending approximately 31mm proximately across the balloon material.The rated burst pressure for this device as per specification is 24 atmospheres.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual and tactile examination found no damage to the tip of the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged in the correct position on the device.This concludes the product analysis.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review performed for the mustang device confirmed that the event of balloon material rupture was defined in the risk documentation and is documented accordingly in the products risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: boston scientific concludes the most probable root cause as adverse event related to patient condition.This cause was selected based on both the results of product analysis and no reported device interaction/ damage or issue until the balloon ruptured when inflated for 5 seconds at the 30 to 40% stenosed.This would suggest that patient anatomy/lesion characteristics most probably contributed to the balloon tear.
Event or Problem Description
It was reported that balloon rupture occurred.The 30-40% stenosed target lesion was located in the non-tortuous and mildly calcified vessel.A 9.0 x 40, 75cm mustang balloon was selected for leg angioplasty.However, during the first inflation, when the balloon was pressurized to 4 kilopascals for 5 seconds, the balloon ruptured.The device was removed slowly, and no device fragments were left inside the patient's body.The procedure was completed with an alternate device.There were no patient complications as a result of this event, and the patient was in good condition post-procedure.

• 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 ; 7634941632
• MDR Report Key: 24318535
• Report Number: 2124215-2026-07863
• Device Sequence Number: 20049311
• Product Code: FGE
• UDI-Device Identifier: 08714729793489
• UDI-Public: (01)08714729793489(17)280116(10)35644878
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: H74939171090470
• Device Catalogue Number: H74939171090470
• Device Lot Number: 0035644878
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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