MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG?; stents, drains and dilators for the biliary ducts

Model Number	H74939171042010
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The balloon was difficult to remove requiring intervention.The target lesion was located in the femoral artery.A 4.0 x 200, 135cm mustang balloon catheter was advanced for dilation.During the procedure, it was noted that the balloon could not fold back spontaneously to the original outer diameter, the resistance was great during withdrawal, and it could not be recaptured in the sheath smoothly.Forced retraction of the balloon caused intimal injury to the blood vessel and punctured the balloon during removal.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D2b: pro code (product code): fge, lit e1: initial reporter facility name: (b)(6) e1: initial reporter address 1: (b)(6) e1: initial reporter phone: (b)(6) g4: premarket / 510(k) #: k103751, k110122, k141521.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50374489
• Report Number: 2124215-2026-45134
• Device Sequence Number: 18613063
• Product Code: FGE
• UDI-Device Identifier: 08714729793595
• UDI-Public: (01)08714729793595(17)280221(10)35906529
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/21/2026

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: H74939171042010
• Device Catalogue Number: H74939171042010
• Device Lot Number: 0035906529
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 08/21/2026
• Supplement Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 02/21/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 143 LB