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

Model Number	H74939171040410
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.G4 - premarket / 510(k): k103751, k110122.Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the arteriovenous fistula.A 4.0 x 40, 135cm mustang balloon catheter was advanced for dilation along with the guidewire.During inflation at 20 atmospheres, the balloon burst.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): k103751, k110122.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the arteriovenous fistula.A 4.0 x 40, 135cm mustang balloon catheter was advanced for dilation along with the guidewire.During inflation at 20 atmospheres, the balloon burst.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 70% stenosed target lesion was located in the moderately tortuous and moderately calcified lesion.
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.G4 - premarket / 510(k): k103751, k110122.The device was returned for analysis.Upon visual inspection, it was determined that the balloon was not folded, indicating that it had been subjected to positive pressure.A balloon pinhole was identified in the balloon material at the proximal markerband.According to the specifications, the rated burst pressure for this device is 24 atmospheres.A visual and tactile examination of the shaft revealed no kinks or damage, and a similar inspection of the tip found no damage as well.Additionally, a visual assessment of the markerbands confirmed that both were undamaged and correctly positioned on the device.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the arteriovenous fistula.A 4.0 x 40, 135cm mustang balloon catheter was advanced for dilation along with the guidewire.During inflation at 20 atmospheres, the balloon burst.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 70% stenosed target lesion was located in the moderately tortuous and moderately calcified lesion.

• 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: 21917064
• Report Number: 2124215-2025-26698
• Device Sequence Number: 8714885
• Product Code: LIT
• UDI-Device Identifier: 08714729793557
• UDI-Public: (01)08714729793557(17)270906(10)34790958
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110122
• 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): 06/18/2025

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: H74939171040410
• Device Catalogue Number: H74939171040410
• Device Lot Number: 0034790958
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 04/27/2025; 06/03/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/23/2025; 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• 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: 35 YR
• Patient Sex: Male
• Patient Weight: 68 KG