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

Model Number	H74939171070670
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.G4 - premarket / 510(k): k141521, k141597.
Event or Problem Description
It was reported that balloon damage occurred.The target lesion was located in the left upper limb arteriovenous fistula.A 7.0 x 60, 75cm mustang balloon catheter was advanced for dilation.During inflation, it was noted that the balloon could not be inflated.When withdrawn and inflated outside the body, it was noted that the balloon was damaged.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon damage occurred the target lesion was located in the left upper limb arteriovenous fistula.A 7.0 x 60, 75 cm mustang balloon catheter was advanced for dilation.During inflation, it was noted that the balloon could not be inflated.When withdrawn and inflated outside the body, it was noted that the balloon was damaged.The procedure was completed with another of the same device.There were no patient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 60% stenosed target lesion was located in the moderately tortuous and mildly calcified vessel.The balloon body was ruptured.There was no visible pinhole noted.
Additional Manufacturer Narrative
D2b: pro code (product code): fge, lit.G4: premarket/510(k): k141521, k141597.E1: initial reporter address 1: (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.A leak test identified a balloon pinhole located approximately 6mm distal of the distal markerband.It is not possible to fully inflate the device with a balloon pinhole.The rated burst pressure for this device as per specification is 20 atmospheres.A visual and tactile examination found the shaft of the device to be kinked at more than one location.A visual and tactile examination found no damage to the tip of the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged in the correct position on the device.
Event or Problem Description
It was reported that balloon damage occurred.The target lesion was located in the left upper limb arteriovenous fistula.A 7.0 x 60, 75cm mustang balloon catheter was advanced for dilation.During inflation, it was noted that the balloon could not be inflated.When withdrawn and inflated outside the body, it was noted that the balloon was damaged.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 target lesion was 60% stenosed, moderately tortuous and mildly calcified.The balloon body was ruptured.There was no visible pinhole noted.
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.G4 - premarket / 510(k): k141521, k141597.

• 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: 21916621
• Report Number: 2124215-2025-26501
• Device Sequence Number: 8650937
• Product Code: FGE
• UDI-Device Identifier: 08714729793861
• UDI-Public: (01)08714729793861(17)260614(10)31822966
• 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
• Report Date (Section B): 07/02/2025

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 Expiration Date: 06/14/2026
• Device Model Number: H74939171070670
• Device Catalogue Number: H74939171070670
• Device Lot Number: 0031822966
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: 04/30/2025; 06/12/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/26/2025; 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 72 KG