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

Model Number	H74939171041510
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code (product code): fge, lit g4: premarket / 510(k) #: k103751, k110122, k141521.
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent a relief and treatment of superficial femoral artery stenosis.A 4.0 x 150, 135cm mustang was used for dilation.During the procedure, it was observed that the balloon burst while being dilated with pressure using an inflator, causing the contrast medium to leak out.After removing the device and attempting dilation again, it was confirmed that the contrast medium had leaked from the balloon.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent a relief and treatment of superficial femoral artery stenosis.A 4.0 x 150, 135cm mustang was used for dilation.During the procedure, it was observed that the balloon burst while being dilated with pressure using an inflator, causing the contrast medium to leak out.After removing the device and attempting dilation again, it was confirmed that the contrast medium had leaked from the balloon.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D2b: pro code (product code): fge, lit.G4: premarket / 510(k) #: k103751, k110122, k141521.Device evaluated by mfr: the device was returned for evaluation.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 deionized (di) water was observed to be leaking from a balloon pinhole located approximately 45mm proximal from the distal markerband.A visual examination of the markerbands identified no issues.A visual and tactile examination identified no kinks or damage to the shaft and no damage to the tip.No other issues were identified during the product 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: 21567039
• Report Number: 2124215-2025-14493
• Device Sequence Number: 14584666
• Product Code: FGE
• UDI-Device Identifier: 08714729793694
• UDI-Public: (01)08714729793694(17)271022(10)35115430
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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: H74939171041510
• Device Catalogue Number: H74939171041510
• Device Lot Number: 0035115430
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown