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

Model Number	H74939171100810
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon leak and rupture occurred.The more than 90% stenosed target lesion was located in the left superficial femoral artery.A 10.0 x 80, 135cm mustang balloon catheter was advanced for dilation.During inflation at 12 atmospheres, the balloon was noted to have an irregular configuration, failing to achieve the desired dilatation effect, and contrast extravasation was visible from the site of balloon rupture.The balloon was fully deflated, and the ruptured balloon catheter was safely withdrawn along with the guidewire.The procedure was completed with another of the same device.There were no patient complications as a result of this event.The patient remained stable following the procedure.
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.E1 - initial reporter facility name: (b)(6)hospital (b)(6).E1 - initial reporter phone: (b)(6).G4 - premarket / 510(k): k141521, k141597.Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.If additional details become available, a supplemental report will be submitted.Investigation results: investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to patient condition.

• 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: 50842870
• Report Number: 2124215-2026-50218
• Device Sequence Number: 15942001
• Product Code: FGE
• UDI-Device Identifier: 08714729795254
• UDI-Public: (01)08714729795254(17)271117(10)35301825
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141521
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939171100810
• Device Catalogue Number: H74939171100810
• Device Lot Number: 0035301825
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 11/17/2024
• 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
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 149 LB