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

Model Number	H74939171120870
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code: (product code): fge, lit.G4: premarket / 510(k): k141521, k141597.Investigation results: device analysis findings: upon receipt at our post market quality assurance laboratory, this mustang device was examined.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 55mm in length and extended from a position 43mm proximal of the distal markerband to 10mm distal of the distal markerband.The recommended introducer/guide sheath size for this device as per mustang product spec, is minimum 7fr sheath.The sheath used by the customer was not returned for analysis.During analysis the investigator was unable to apply a vacuum to the device due to the longitudinal tear and was unable to advance the device through a boston scientific 7fr sheath.So therefore, the sheath insertion test cannot be carried out so the event cannot be confirmed.A visual and tactile examination found no kinks or damage to the shaft of the returned device.A visual examination identified no damage to the tip of the device.Dhr (device history record) review: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: updated: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review performed for the gladiator device confirmed that the events of catheter- difficult to advance through the guide catheter was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Conclusion: based on a thorough review of the reported complaint, boston scientific concludes the most probable root cause as adverse event related to procedure.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2026.It was reported that difficulty advancing occurred.The target lesion was located in the arteriovenous fistula.A 12.0 x 80, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, a resistance was encountered when advancing the device through the sheath.The procedure was completed with another of same device.There were no patient complications reported as a result of this event.The patient remained stable post-procedure.However, result of the device analysis revealed longitudinal tear in the balloon material.

• 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 ; 7634941632
• MDR Report Key: 25749332
• Report Number: 2124215-2026-36543
• Device Sequence Number: 10413281
• Product Code: FGE
• UDI-Device Identifier: 08714729794745
• UDI-Public: (01)08714729794745(17)280922(10)37518464
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/08/2026

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: H74939171120870
• Device Catalogue Number: H74939171120870
• Device Lot Number: 0037518464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2025
• 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: 61 YR
• Patient Sex: Female