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

Model Number	H74939171090270
Medical Device Problem Codes	Contamination (1120); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported blue material was found upon flushing.A 9.0 x 20, 75cm mustang was selected for use in a procedure.During device preparation, blue material was observed during flushing.The source of the material could not be confirmed, however, the customer reported that it appeared to have originated from the balloon.There were no patient injury as a result of this event.
Additional Manufacturer Narrative
G4 - premarket / 510(k) #:k141521, k141597.
Additional Manufacturer Narrative
B3 - date of event: used 09/01/2025 as the event date was not reported.Upon receipt at our post market quality assurance laboratory, the device was returned inserted in the protective hoop.The investigator removed the device from the hoop.A visual examination of the returned device found that the balloon had been inflated and was not refolded.It is not known when the balloon was subjected to positive pressure.A visual and tactile examination identified no kinks or damage to the shaft, tip, or markerbands.The foreign material (fm) was returned on a foam pad and sent to the material characterization lab for additional analysis.Fourier transform infra-red spectroscopy (ftir) was performed using peak locations and relative intensities, then comparison with other known reference samples was able to find a good match for this fm with bleached cotton.There are documented controls in place throughout the manufacturing process to ensure that the customer does not receive a device which is outside of specification.
Event or Problem Description
It was reported blue material was found upon flushing.A 9.0 x 20, 75cm mustang was selected for use in a procedure.During device preparation, blue material was observed during flushing.The source of the material could not be confirmed, however, the customer reported that it appeared to have originated from the balloon.There were no patient injury as a result of this event.

• 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: 23233639
• Report Number: 2124215-2025-70306
• Device Sequence Number: 18319539
• Product Code: LIT
• UDI-Device Identifier: 08714729793755
• UDI-Public: (01)08714729793755(17)280130(10)35723264
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: H74939171090270
• Device Catalogue Number: H74939171090270
• Device Lot Number: 0035723264
• 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: 09/10/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 10/07/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• 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 Sex: Unknown