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

Model Number	H74939171060440
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code: (product code): fge, lit.G4: premarket / 510(k): k141521, k141597.
Event or Problem Description
It was reported that balloon detachment occurred.The 90% stenosed target lesion was located in the non-tortuous and non-calcified vessel.A 6.0 x 40, 40cm mustang balloon catheter was selected for use.Upon unpacking the sterile pouch and taking the hoop out, it was observed that the balloon was not securely attached to the hoop, resulting in balloon detachment.The procedure was completed with a different device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon detachment occurred.The 90% stenosed target lesion was located in the non-tortuous and non-calcified vessel.A 6.0 x 40, 40cm mustang balloon catheter was selected for use.Upon unpacking the sterile pouch and taking the hoop out, it was observed that the balloon was not securely attached to the hoop, resulting in balloon detachment.The procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D2b: pro code: (product code): fge, lit.G4: premarket / 510(k): k141521, k141597.A mustang device was received for analysis.The device was received with the balloon protector still on the balloon.The investigator removed the balloon protector.The balloon was tightly folded and was not subject to positive pressure.A visual examination of the markerbands identified no issues.A visual and tactile examination identified no kinks or damage to the shaft.A visual and tactile examination identified no damage to the tip.
Additional Manufacturer Narrative
D2b: pro code: (product code): fge, lit.G4: premarket / 510(k): k141521, k141597.H6 - device codes: corrected.
Event or Problem Description
It was reported that balloon detachment occurred.The 90% stenosed target lesion was located in the non-tortuous and non-calcified vessel.A 6.0 x 40, 40cm mustang balloon catheter was selected for use.Upon unpacking the sterile pouch and taking the hoop out, it was observed that the balloon was not securely attached to the hoop, resulting in balloon detachment.The procedure was completed with a different device.There were no patient complications as a result of this event.It was further reported that upon unpacking the sterile pouch and taking the hoop out, the balloon was not securely attached to the hoop, the entire balloon catheter slipped out of the protective hoop.

• 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: 23457248
• Report Number: 2124215-2025-76768
• Device Sequence Number: 8961310
• Product Code: FGE
• UDI-Device Identifier: 08714729793564
• UDI-Public: (01)08714729793564(17)271209(10)35445768
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2026

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: H74939171060440
• Device Catalogue Number: H74939171060440
• Device Lot Number: 0035445768
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 12/03/2025; 12/15/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/05/2025; 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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
• Patient Sex: Unknown