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

Model Number	H74939171040470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b pro code (product code): fge, lit.G4 premarket/510(k) #: k103751, k110122.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the radial artery.A 4.0 x 40, 75 cm mustang balloon catheter was advanced for dilation.During the procedure, the balloon burst just before the pressure reached.The procedure was completed without any abnormalities.
Additional Manufacturer Narrative
D2b pro code (product code): fge, lit.G4 premarket / 510(k) #: k103751, k110122.B1: updated with product problem.Device evaluation by manufacturer: the mustang device was returned for analysis.A visual examination identified that the balloon was tightly folded with the balloon protector on and was not subjected to positive pressure.The rated burst pressure for this device is 24 atmospheres as per mustang specification.The returned device was attached to an encore inflation unit.The balloon protector was removed, and the device was inflated to its rated burst pressure of 24 atmospheres 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 and tip.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the radial artery.A 4.0 x 40, 75cm mustang balloon catheter was advanced for dilation.During the procedure, the balloon burst just before the pressure reached.The procedure was completed without any abnormalities.

• 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: 21542884
• Report Number: 2124215-2025-14074
• Device Sequence Number: 7098990
• Product Code: FGE
• UDI-Device Identifier: 08714729793403
• UDI-Public: (01)08714729793403(17)260214(10)31046171
• 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
• Report Date (Section B): 04/28/2025

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: 02/14/2026
• Device Model Number: H74939171040470
• Device Catalogue Number: H74939171040470
• Device Lot Number: 0031046171
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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