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

Model Number	H74939171100610
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code (product code):fge, lit g4: premarket / 510(k) #: k141521, k141597.E1: initial reporter facility name: (b)(6).Good faith effort attempts were made to try and retrieve additional details regarding the reported device, but further information was unable to be obtained.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the gastric coronary vein.A non boston scientific stent 10.0 mm x 60 mm, 135 cm and mustang balloon catheter 10.0 mm x 60 mm, 135 cm were used.During deployment, air leakage was observed in the balloon despite external priming.The procedure was completed using a replacement device of the same type.Post procedural angiography confirmed proper stent placement and patent blood flow.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D2.B.: pro code (product code): fge, lit.G4: premarket / 510(k) #: k141521, k141597.E1: initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the gastric coronary vein.A non-boston scientific stent 10.0 mm x 60 mm, 135 cm and mustang balloon catheter 10.0 mm x 60 mm, 135 cm were used.During deployment, air leakage was observed in the balloon despite external priming.The procedure was completed using a replacement device of the same type.Post procedural angiography confirmed proper stent placement and patent blood flow.There were no patient complications as a result of this event.It was further reported that 80% stenosed target lesion was located in the severely tortuous and severely calcified vein.
Additional Manufacturer Narrative
D2b: pro code (product code):fge, lit.G4: premarket / 510(k) #: k141521, k141597.E1: initial reporter facility name: (b)(6).Device evaluated by mfr: the mustang was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The rated burst pressure for this device is 14 atmospheres as per mustang specification (#90519237).The returned device was attached to an encore inflation unit.Positive pressure was applied when di water was observed to be leaking from a balloon pinhole located approximately 17mm distal from the proximal markerband.A visual examination of the markerbands identified no issues.A visual and tactile examination identified no kinks or damage to the shaft.A visual and tactile examination identified no damage to the tip.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the gastric coronary vein.A non boston scientific stent 10.0 mm x 60 mm, 135 cm and mustang balloon catheter 10.0 mm x 60 mm, 135 cm were used.During deployment, air leakage was observed in the balloon despite external priming.The procedure was completed using a replacement device of the same type.Post-procedural angiography confirmed proper stent placement and patent blood flow.There were no patient complications as a result of this event.It was further reported that 80% stenosed target lesion was located in the severely tortuous and severely calcified vein.
Additional Manufacturer Narrative
A1: patient identifier: updated.E1: initial reporter zip/post code: updated.D2b: pro code (product code):fge, lit.G4: premarket / 510(k) #: k141521, k141597.E1: initial reporter facility name: (b)(6).Device evaluated by mfr: the mustang was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The rated burst pressure for this device is 14 atmospheres as per mustang specification (#(b)(6)).The returned device was attached to an encore inflation unit.Positive pressure was applied when di water was observed to be leaking from a balloon pinhole located approximately 17mm distal from the proximal markerband.A visual examination of the markerbands identified no issues.A visual and tactile examination identified no kinks or damage to the shaft.A visual and tactile examination identified no damage to the tip.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the gastric coronary vein.A non boston scientific stent 10.0 mm x 60 mm, 135 cm and mustang balloon catheter 10.0 mm x 60 mm, 135 cm were used.During deployment, air leakage was observed in the balloon despite external priming.The procedure was completed using a replacement device of the same type.Post-procedural angiography confirmed proper stent placement and patent blood flow.There were no patient complications as a result of this event.It was further reported that 80% stenosed target lesion was located in the severely tortuous and severely calcified vein.

• 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: 22835278
• Report Number: 2124215-2025-57607
• Device Sequence Number: 10200088
• Product Code: FGE
• UDI-Device Identifier: 08714729795230
• UDI-Public: (01)08714729795230(17)271113(10)35271057
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/11/2025

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: H74939171100610
• Device Catalogue Number: H74939171100610
• Device Lot Number: 0035271057
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 09/08/2025; 10/03/2025; 11/21/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 10/02/2025; 10/27/2025; 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2024
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 61 KG