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

Model Number	H74939171070870
Medical Device Problem Codes	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	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 7.0 x 80, 75cm mustang balloon catheter was advanced for dilation.During the procedure, it was noted that the balloon burst.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.G4 - premarket / 510(k): fge, lit.
Additional Manufacturer Narrative
B5 - describe event or problem updated.D2b - pro code (product code): fge, lit.G4 - premarket / 510(k): fge, lit.
Event or Problem Description
It was reported that balloon rupture occurred.A 7.0 x 80, 75cm mustang balloon catheter was advanced for dilation.During the procedure, it was noted that the balloon burst.There were no patient complications as a result of this event.It was further reported that the 100% stenosed target lesion was located in the severely tortuous and severely calcified arteriovenous fistula (avf).The balloon ruptured for 1 minute.The procedure was completed with the same device.The patient was in good condition post procedure.
Event or Problem Description
It was reported that balloon rupture occurred.A 7.0 x 80, 75cm mustang balloon catheter was advanced for dilation.During the procedure, it was noted that the balloon burst.There were no patient complications as a result of this event.It was further reported that the 100% stenosed target lesion was located in the severely tortuous and severely calcified arteriovenous fistula (avf).The balloon ruptured for 1 minute.The procedure was completed with the same device.The patient was in good condition post procedure.
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.G4 - premarket / 510(k): k141521, k141597.With the available information, boston scientific concludes: device history record (dhr) review, it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Device technical analysis the mustang device was returned for evaluation.A visual examination identified that the balloon was not folded, which indicates that the device was subjected to positive pressure.A leak test was carried out, and the balloon was inflated to its rated burst pressure for 30 seconds using deionized water and digital timer, without issue.A vacuum was then applied.The inflation device was verified at 20 atmospheres, before and after use with calibrated pressure gauge.This inflation to rate of burst pressure was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.As per specification, the rated burst pressure for this device is 20 atmospheres.No issues were noted with the tip of the device.A visual examination found no issue with the markerbands.A visual and tactile examination found a shaft kink/ stretched approximately 110mm proximal from the distal tip.No other issues were identified during the product analysis.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 completed 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, boston scientific concludes the most probable root cause as no problem detected, based on the results of the product analysis, and as the investigator inflated the balloon to its rated burst pressure of 20 atmospheres, with no leaks or issues noted, so the complaint incident cannot be confirmed.The unreported kink noted during device analysis occurred most likely as a result of interaction between the user and the device (unintended), at which stage of the procedure it occurred (during procedure/handling post procedure) cannot be established.

• 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: 23745756
• Report Number: 2124215-2025-89623
• Device Sequence Number: 15556814
• Product Code: FGE
• UDI-Device Identifier: 08714729794264
• UDI-Public: (01)08714729794264(17)280816(10)37226744
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2026

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: H74939171070870
• Device Catalogue Number: H74939171070870
• Device Lot Number: 0037226744
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 12/16/2025; 02/17/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/12/2026; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2025
• 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