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

Model Number	H74939171070470
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon failed to deflate properly.The 60% stenosed target lesion was located in the iliac artery.The vessel exhibited more than moderate tortuosity and mild calcification.A 7.0 x 40 mm, 75 cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon was inflated to nominal pressure and held for approximately 30 seconds.However, the balloon did not deflate properly.There was no issue removing the device even though it did not deflate properly.The balloon could not be reused to re-cross the lesion, so the procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6) reported here as phone number exceeded character limit for designated field.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6) reported here as phone number exceeded character limit for designated field.Investigation results: the device is not expected to be returned for analysis; therefore, a technical analysis could not be performed.Device history record: 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: 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 mustang device defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefits for the product.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.
Event or Problem Description
It was reported that the balloon failed to deflate properly.The 60% stenosed target lesion was located in the iliac artery.The vessel exhibited more than moderate tortuosity and mild calcification.A 7.0 x 40 mm, 75 cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon was inflated to nominal pressure and held for approximately 30 seconds.However, the balloon did not deflate properly.There was no issue removing the device even though it did not deflate properly.The balloon could not be reused to re-cross the lesion, so the procedure was completed with another of the same device.There were no patient complications 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23810890
• Report Number: 2124215-2025-86791
• Device Sequence Number: 9270432
• Product Code: FGE
• UDI-Device Identifier: 08714729793342
• UDI-Public: (01)08714729793342(17)280723(10)37044690
• 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,Followup
• Report Date (Section B): 04/14/2026

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: H74939171070470
• Device Catalogue Number: H74939171070470
• Device Lot Number: 0037044690
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2025
• 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: 82 YR
• Patient Sex: Male