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

Model Number	H74939171061070
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
F1 - initial reporter facility name: (b)(6).E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred requiring additional intervention.The target lesion was located in the arteriovenous fistula.A 6.0 x 100, 75cm mustang balloon catheter was advanced for dilation.During inflation, the balloon ruptured and could not be removed.The blood vessel was incised to remove the balloon completely.There were no further patient complications as a result of this event.
Additional Manufacturer Narrative
F1 - initial reporter facility name: (b)(6).E1 - initial reporter phone: (b)(6).Updated fields: h6 - impact codes: updated from f1901 to f19 to better reflect the intervention performed.H6 - evaluation method codes, evaluation conclusion codes.
Event or Problem Description
It was reported that balloon rupture occurred requiring additional intervention.The target lesion was located in the arteriovenous fistula.A 6.0 x 100, 75cm mustang balloon catheter was advanced for dilation.During inflation, the balloon ruptured and could not be removed.The blood vessel was incised to remove the balloon completely.There were no further patient complications as a result of this event.It was further reported that there was no part of the balloon separated or detached when it ruptured.

• 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: 23789469
• Report Number: 2124215-2025-90567
• Device Sequence Number: 5522057
• Product Code: FGE
• UDI-Device Identifier: 08714729793625
• UDI-Public: (01)08714729793625(17)270709(10)34390579
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 01/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939171061070
• Device Catalogue Number: H74939171061070
• Device Lot Number: 0034390579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/20/2026
• Date Device Manufactured: 07/09/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Unknown
• Patient Weight: 65 KG