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

Model Number	H74939171060870
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	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified arteriovenous shunt.A 6.0 x 80, 75cm mustang balloon catheter was advanced for dilation.During the first inflation, the balloon burst before it reached the nominal burst pressure (nbp).The device was removed without any problem, 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
E1 - pro code (product code): fge, lit.E1 - initial reporter facility name: (b)(6).E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).G4 - premarket / 510(k) #: k141521, k141597.
Event or Problem Description
It was reported that a balloon rupture occurred.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified arteriovenous shunt.A 6.0 x 80, 75cm mustang balloon catheter was advanced for dilation.During the first inflation, the balloon burst before it reached the nominal burst pressure (nbp).The device was removed without any problem, 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 the patient did not have a challenging anatomy, and the procedure was carried out following the standard protocol.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information e1 - pro code (product code): (b)(6).E1 - initial reporter facility name: (b)(6).E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).G4 - premarket / 510(k) #: k141521, k141597.Device evaluated by mfr: the mustang device was returned to our post market quality assurance laboratory.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied when di water was observed to be leaking from the inner shaft and coming out of the tip.No issues were noted with the tip section of the device.A visual examination found no issue with the markerbands.A visual and tactile examination identified a shaft kink approximately 570mm proximal from the distal tip.This concludes the product analysis.

• 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: 22824928
• Report Number: 2124215-2025-57288
• Device Sequence Number: 4577544
• Product Code: FGE
• UDI-Device Identifier: 08714729793854
• UDI-Public: (01)08714729793854(17)280207(10)35794465
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 11/05/2025

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: H74939171060870
• Device Catalogue Number: H74939171060870
• Device Lot Number: 0035794465
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2025
• 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