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

Model Number	H74939171070440
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): lit.G4 - premarket / 510(k) #: k141597.
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in a shunt in a moderately tortuous and non-calcified vein.A 7.0 x 40, 40cm mustang balloon catheter was advanced for dilatation.However, during the second inflation at 20 atmospheres, the balloon ruptured.The device was removed, and the procedure was completed with another of same device.No patient complications were reported, and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
D2b - pro code (product code): lit.G4 - premarket / 510(k) #: k141597.Device evaluated by mfr.: a mustang device batch was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured 23mm in length and extended from a position 1mm proximal of the proximal markerband to 15mm distal of the distal markerband.Visual examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in a shunt in a moderately tortuous and non-calcified vein.A 7.0 x 40, 40cm mustang balloon catheter was advanced for dilatation.However, during the second inflation at 20 atmospheres, the balloon ruptured.The device was removed, and the procedure was completed with another of same device.No patient complications were reported, and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
D4 - unique identifier (udi) #: updated from (b)(4).D2b - pro code (product code): fge, lit.G4 - premarket / 510(k) #: k141521, k141597.Device evaluated by mfr.: a mustang device batch was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured 23mm in length and extended from a position 1mm proximal of the proximal markerband to 15mm distal of the distal markerband.Visual examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in a shunt in a moderately tortuous and non-calcified vein.A 7.0 x 40, 40cm mustang balloon catheter was advanced for dilatation.However, during the second inflation at 20 atmospheres, the balloon ruptured.The device was removed, and the procedure was completed with another of same device.No patient complications were reported, and the patient was in good condition after the procedure.

• 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: 21356545
• Report Number: 2124215-2025-07458
• Device Sequence Number: 20768708
• Product Code: FGE
• UDI-Device Identifier: 08714729793588
• UDI-Public: (01)08714729793588(17)270920(10)34890201
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 04/04/2025

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: H74939171070440
• Device Catalogue Number: H74939171070440
• Device Lot Number: 0034890201
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 03/13/2025; 04/04/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 04/01/2025; 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2024
• 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 Sex: Unknown