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	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the subclavian vein.A 9.0 x 40, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon burst during angioplasty within the normal usable pressure range, requiring replacement with another balloon.The device was removed without any problem.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the subclavian vein.A 9.0 x 40, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon burst during angioplasty within the normal usable pressure range, requiring replacement with another balloon.The device was removed without any problem.There were no patient complications as a result of this event.It was further reported that the 60% stenosed target lesion was located in the mildly tortuous and non calcified lesion and the balloon inflated once under rated burst pressure for 30 seconds.
Additional Manufacturer Narrative
Correction for b5 event description.
Additional Manufacturer Narrative
Device technical analysis: a visual examination identified that the balloon was not folded, indicating that the balloon had been subjected to positive pressure.The rated burst pressure for this device is 18 atmospheres per mustang specifications.The returned device was received attached to an inflation unit.Positive pressure was applied, at which time deionized (di) water was observed leaking from a pinhole in the balloon material located approximately 4 mm proximal to the distal marker band.A visual examination of the marker bands identified no issues.A visual and tactile examination of the shaft identified no kinks or damage.A visual and tactile examination of the tip identified no damage.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 was performed for the mustang balloon catheter and confirmed that the event of balloon - material rupture was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, the most probable cause of this event was determined to be an adverse event related to the patient condition.There was no reported device interaction, damage, or issue noted until inflation was attempted at the 60% stenosed, mildly tortuous lesion site.This suggests that the patient anatomy and lesion characteristics most likely contributed to the balloon pinhole leak.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the subclavian vein.A 9.0 x 40, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon burst during angioplasty within the normal usable pressure range, requiring replacement with another balloon.The device was removed without any problem.There were no patient complications as a result of this event.It was further reported that the 60% stenosed target lesion was located in the mildly tortuous and non calcified lesion and the balloon inflated once under rated burst pressure for 30 seconds.

• 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: 24021656
• Report Number: 2124215-2026-01548
• Device Sequence Number: 10591005
• Product Code: LIT
• UDI-Device Identifier: 08714729793489
• UDI-Public: (01)08714729793489(17)280422(10)36351215
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K141597
• 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,Followup
• Report Date (Section B): 03/13/2026

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: 0036351215
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 12/27/2025; 02/18/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/26/2026; 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2025
• 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 Age: 64 YR
• Patient Sex: Female