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

Model Number	H74939171120670
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 12.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured at nominal pressure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Detailed information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that balloon rupture occurred.A 12.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured at nominal pressure.There were no patient complications as a result of this event.It was further reported that the target lesion, exhibiting 70% stenosis, was located in a vessel with moderate tortuosity and moderate calcification.The balloon was inflated once, and the procedure was completed using another device of the same type.
Event or Problem Description
It was reported that balloon rupture occurred.A 12.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured at nominal pressure.There were no patient complications as a result of this event.It was further reported that the target lesion, exhibiting 70% stenosis, was located in a vessel with moderate tortuosity and moderate calcification.The balloon was inflated once, and the procedure was completed using another device of the same type.
Additional Manufacturer Narrative
The device was returned for analysis.Upon visual inspection, it was determined that the balloon was not folded, suggesting that it had been subjected to positive pressure.A longitudinal tear measuring approximately 75mm in length was identified in the balloon material, extending from 8mm proximal to the proximal marker band to 6mm distal to the distal marker band.No damage was observed to the tip of the device during the visual examination.Additionally, a combined visual and tactile inspection revealed no kinks or damage to the shaft of the device.Both marker bands remained undamaged and were still present on the shaft.

• 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: 22034813
• Report Number: 2124215-2025-30759
• Device Sequence Number: 9412122
• Product Code: LIT
• UDI-Device Identifier: 08714729794738
• UDI-Public: (01)08714729794738(17)271218(10)35514326
• 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,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 Model Number: H74939171120670
• Device Catalogue Number: H74939171120670
• Device Lot Number: 0035514326
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 05/14/2025; 06/26/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 06/04/2025; 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2024
• 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: 61 YR
• Patient Sex: Male