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

Model Number	H74939171120470
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
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.A dialysis patient underwent percutaneous transluminal angioplasty (pta) in the severely calcified cephalic artery.A 12.0 x 40, 75cm mustang balloon catheter was advanced for dilation.During the procedure, the balloon ruptured.Upon checking, it was noted that the contrast was leaking liquid.The procedure was completed with a different device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon rupture occurred.A dialysis patient underwent percutaneous transluminal angioplasty (pta) in the severely calcified cephalic artery.A 12.0 x 40, 75 cm mustang balloon catheter was advanced for dilation.During the procedure, the balloon ruptured.Upon checking, it was noted that the contrast was leaking liquid.The procedure was completed with a different 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.Device evaluated by mfr: the mustang was returned for analysis a visual examination identified that the balloon was tightly folded, which indicates that the device was not subjected to positive pressure.The returned device was attached to an inflation unit and positive pressure was applied.The balloon was inflated to its rate of burst pressure of 14 atmospheres for 30 seconds using deionizes water and digital timer: g24610, without issue.A vacuum was then applied.The inflation device was verified at 14 atmospheres, before and after use with calibrated pressure gauge g19252.This inflation to rate of burst pressure of 14 atmospheres was repeated three times with no leaks or drop in pressure noted.No issues were identified with the balloon material.No issues were noted with the tip of the device.A visual examination found no issue with the markerbands.A visual and tactile examination identified no issues with the shaft of the device.

• 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: 22115389
• Report Number: 2124215-2025-34620
• Device Sequence Number: 4109854
• Product Code: FGE
• UDI-Device Identifier: 08714729793441
• UDI-Public: (01)08714729793441(17)250617(10)29613938
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K141597
• 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): 07/21/2025

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 Expiration Date: 06/17/2025
• Device Model Number: H74939171120470
• Device Catalogue Number: H74939171120470
• Device Lot Number: 0029613938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2022
• 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: 70 YR
• Patient Sex: Male