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

Model Number	H74939171080470
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon ruptured and could not be retrieved.The patient presented with in-stent restenosis (isr) of a mildly tortuous iliac artery.A mustang balloon catheter was advanced to the target lesion and inflated to the rated burst pressure.After 1.5 minutes, the pressure dropped on the inflation device and there was blood inside the balloon catheter which indicated a balloon rupture.Retrieval of the balloon catheter was difficult.Angiography showed that the two radiopaque markers on the balloon moved independently of each other which suggested a non-longitudinal burst.An attempt to remove the balloon and sheath together resulted only in the retrieval of only the inner wire and sheath of the balloon catheter, while the majority of the ballon remain in situ.The balloon rupture had occurred at the proximal balloon segment.The patient was transferred to the operation room (or) for surgical removal.However, due to previously implanted vascular patches, extraction was difficult and ultimately unsuccessful.The vascular surgeon confirmed that blood flow was not obstructed by the retained ballon material, and it was left in place for the time being.There were no patient complications as a result of the event.The patient is at home and doing well.Flow in the leg was sufficient, and there was no extra procedure planned.
Event or Problem Description
It was reported that the balloon ruptured and could not be retrieved.The patient presented with in-stent restenosis (isr) of a mildly tortuous iliac artery.A mustang balloon catheter was advanced to the target lesion and inflated to the rated burst pressure.After 1.5 minutes, the pressure dropped on the inflation device and there was blood inside the balloon catheter which indicated a balloon rupture.Retrieval of the balloon catheter was difficult.Angiography showed that the two radiopaque markers on the balloon moved independently of each other which suggested a non-longitudinal burst.An attempt to remove the balloon and sheath together resulted only in the retrieval of only the inner wire and sheath of the balloon catheter, while the majority of the balloon remain in situ.The balloon rupture had occurred at the proximal balloon segment.The patient was transferred to the operation room (or) for surgical removal.However, due to previously implanted vascular patches, extraction was difficult and ultimately unsuccessful.The vascular surgeon confirmed that blood flow was not obstructed by the retained balloon material, and it was left in place for the time being.There were no patient complications as a result of the event.The patient is at home and doing well.Flow in the leg was sufficient, and there was no extra procedure planned.
Additional Manufacturer Narrative
Device eval by mfr: the device was returned, and analysis was completed.The device was returned with the proximal section of the device inserted in the customer introducer sheath.A visual and tactile examination found the shaft of the device to have completely detached at two locations.The first shaft break was at approximately 700 mm distal from the distal end of the strain relief.The distal section that was detached was not returned, consisted of part of the balloon section, markerbands and tip.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A complete balloon circumferential tear was identified, located approximately 10mm distal of the proximal balloon bond.The proximal section of balloon was not returned along with part of shaft, markerbands and distal tip.The tip section of the device was not returned.A visual examination found the markerband to have completely detached from the device.The detached markerbands was not returned for 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: 22947815
• Report Number: 2124215-2025-58673
• Device Sequence Number: 15718707
• Product Code: FGE
• UDI-Device Identifier: 08714729793328
• UDI-Public: (01)08714729793328(17)280317(10)36090012
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939171080470
• Device Catalogue Number: H74939171080470
• Device Lot Number: 0036090012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown