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

Model Number	H74939171061570
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	06/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified arteriovenous fistula.A 6.0 x 150, 75cm mustang balloon catheter was advanced for dilation.However, it was noted that the balloon ruptured at 10 atmospheres.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) #: k103751, k110122, k141521.
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.G4 - premarket / 510(k) #: k103751, k110122, k141521.Device evaluated by mfr: the mustang device was returned to our post market quality assurance laboratory.A visual and tactile examination identified shaft damage 190mm proximal from the distal tip.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was present in the balloon.The rated burst pressure for this device is 22 atmospheres as per mustang specification.The returned device was attached to an encore inflation unit.Positive pressure was applied when di water was observed to be leaking from the shaft where the shaft damage was noted.The balloon was unable to fully inflate to its rated burst pressure due to the shaft leak.A visual examination of the markerbands identified no issues.A visual and tactile examination identified no damage to the tip.This concludes the product analysis.
Event or Problem Description
It was reported that a balloon rupture occurred.The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified arteriovenous fistula.A 6.0 x 150, 75cm mustang balloon catheter was advanced for dilation.However, it was noted that the balloon ruptured at 10 atmospheres.There were no patient complications as a result of this event.It was further reported that the balloon ruptured upon first inflation for 30 seconds during the procedure.The device was removed without any problem, and the procedure was completed with another of the same device.The patient was in good condition post-procedure.
Event or Problem Description
It was reported that a balloon rupture occurred.The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified arteriovenous fistula.A 6.0 x 150, 75cm mustang balloon catheter was advanced for dilation.However, it was noted that the balloon ruptured at 10 atmospheres.There were no patient complications as a result of this event.It was further reported that the balloon ruptured upon first inflation for 30 seconds during the procedure.The device was removed without any problem, and the procedure was completed with another of the same device.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.D2b - pro code (product code): fge, lit.G4 - premarket / 510(k) #: k103751, k110122, k141521.

• 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: 22210130
• Report Number: 2124215-2025-39341
• Device Sequence Number: 8659701
• Product Code: FGE
• UDI-Device Identifier: 08714729793984
• UDI-Public: (01)08714729793984(17)280303(10)35981289
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K103751
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2025

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: H74939171061570
• Device Catalogue Number: H74939171061570
• Device Lot Number: 0035981289
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 06/18/2025; 07/30/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/06/2025; 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2025
• 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: 73 YR
• Patient Sex: Male