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

Model Number	H74939171052010
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code: fge, lit.G4: premarket/510(k): k103751, k110122, k141521.E1: initial reporter facility name: (b)(6) hospital; (b)(6) hospital.Device evaluated by mfr.: 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.The rated burst pressure for this device is 24 atmospheres as per mustang specification.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 80 mm distal from the proximal markerband.Visual examination of the markerbands identified no issues.A visual and tactile examination identified no kinks or damage to the shaft and tip.
Event or Problem Description
Reportable based on device analysis completed on 04dec2025.It was reported that balloon leak occurred.The target lesion located in the lower extremity artery was prepared by manual heparin-saline infusion and irrigation.A 5.0 x 200, 135cm mustang balloon catheter was then advanced for dilatation but during pressurization, the balloon could not be expanded normally, and angiography showed contrast medium leakage; however, no physical damage was noted on the balloon.The procedure was completed with a non-boston scientific balloon catheter.No patient complications as a result of this event and the patient condition were stable post-procedure.However, returned device analysis revealed balloon pinhole.

• 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: 23933208
• Report Number: 2124215-2025-93878
• Device Sequence Number: 20240426
• Product Code: FGE
• UDI-Device Identifier: 08714729793373
• UDI-Public: (01)08714729793373(17)280304(10)35992094
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103751
• 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
• Report Date (Section B): 12/31/2025

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: H74939171052010
• Device Catalogue Number: H74939171052010
• Device Lot Number: 0035992094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2025
• 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
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 50 KG