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

Model Number	H74939171062070
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b.Pro code (product code): fge, lit.E1.Initial reporter phone: (b)(6).G4.Premarket / 510(k) #: k103751, k110122, k141521.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the arteriovenous fistula (avf).A 6.0 x 200, 75cm mustang balloon catheter was selected for use.During the procedure, the balloon ruptured while being inflated inside the patient body.The procedure was completed with another of same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.D2b - pro code (product code): fge, lit.E1 - initial reporter phone: (b)(6).E1 - initial reporter email: added.G4 - premarket / 510(k) #: k103751, k110122, k141521.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the arteriovenous fistula (avf).A 6.0 x 200mm,75cm mustang balloon catheter was selected for use.During the procedure, the balloon ruptured while being inflated inside the patient's body.The procedure was completed with another of same device.There were no patient complications as a result of this event.It was further reported that the target lesion was severely tortuous and moderately calcified.The balloon was ruptured during first inflation for 30 seconds.
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.E1 - initial reporter phone: (b)(6).G4 - premarket / 510(k) #: k103751, k110122, k141521.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 balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured approximately 35mm in length and was located in the mid region of the balloon.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 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 adverse event related to patient condition, based on the results of product analysis, there being no reported device interaction/ damage or issue until inflation was attempted at the severely tortuous and moderately calcified lesion site.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 target lesion was located in the arteriovenous fistula (avf).A 6.0 x 200mm,75cm mustang balloon catheter was selected for use.During the procedure, the balloon ruptured while being inflated inside the patient's body.The procedure was completed with another of same device.There were no patient complications as a result of this event.It was further reported that the target lesion was severely tortuous and moderately calcified.The balloon was ruptured during first inflation 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: 23892348
• Report Number: 2124215-2025-93054
• Device Sequence Number: 20169444
• Product Code: FGE
• UDI-Device Identifier: 08714729794509
• UDI-Public: (01)08714729794509(17)280722(10)37034923
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2026

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: H74939171062070
• Device Catalogue Number: H74939171062070
• Device Lot Number: 0037034923
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 01/09/2026; 02/20/2026
• Initial Report FDA Received Date: 12/25/2025
• Supplement Report FDA Received Date: 02/03/2026; 03/16/2026
• 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 Age: 70 YR
• Patient Sex: Female