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

Model Number	H74939171060440
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
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 rupture occurred.The stenosed target lesion was located in the artificial arteriovenous fistula.A 6.0 x 40, 40cm mustang balloon catheter was selected for use.During the procedure, the balloon was dilated once at 22 atmospheres (atm) less than the bursting pressure.After 40 seconds, it was observed that the balloon pressure was decreased, and the balloon was damaged and longitudinally ruptured were noted.The device was removed, and the procedure was completed with another of the same 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.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the artificial arteriovenous fistula.A 6.0 x 40, 40cm mustang balloon catheter was selected for use.During the procedure, the balloon was dilated once at 22 atmospheres (atm) less than the bursting pressure.After 40 seconds, it was observed that the balloon pressure was decreased, and the balloon was damaged and longitudinally ruptured were noted.The device was removed, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that 80% stenosed target lesion was located in the mild tortuous and moderately calcified vessel.The balloon ruptured upon first inflation at 21 atmospheres (atm).The expansion pressure was less than the burst pressure.After 35 seconds, it was found that the pressure had decreased and the balloon was damaged.The balloon was withdrawn from the patient due to pressure relief caused by the damaged balloon.
Additional Manufacturer Narrative
D2b: pro code (product code): fge, lit.G4: premarket / 510(k) #: k141521, k141597.Device evaluated by mfr: the mustang was returned for analysis.Visual examination of the returned device found that the balloon was tightly folded and did not appear to be subjected to positive pressure.The investigator inflated the balloon to its rated burst pressure with no leaks or issues noted.A visual examination of the markerbands identified no issues.A visual and tactile examination identified no kinks or damage to the shaft.A visual examination of the distal tip identified damage.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the artificial arteriovenous fistula.A 6.0 x 40, 40cm mustang balloon catheter was selected for use.During the procedure, the balloon was dilated once at 22 atmospheres (atm) less than the bursting pressure.After 40 seconds, it was observed that the balloon pressure was decreased, and the balloon was damaged and longitudinally ruptured were noted.The device was removed, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that 80% stenosed target lesion was located in the mild tortuous and moderately calcified vessel.The balloon ruptured upon first inflation at 21 atmospheres (atm).The expansion pressure was less than the burst pressure.After 35 seconds, it was found that the pressure had decreased and the balloon was damaged.The balloon was withdrawn from the patient due to pressure relief caused by the damaged balloon.

• 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: 22916491
• Report Number: 2124215-2025-60676
• Device Sequence Number: 13207352
• Product Code: FGE
• UDI-Device Identifier: 08714729793564
• UDI-Public: (01)08714729793564(17)270813(10)34625987
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 12/01/2025

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: H74939171060440
• Device Catalogue Number: H74939171060440
• Device Lot Number: 0034625987
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: 09/22/2025; 11/10/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 10/15/2025; 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 60 KG