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

Model Number	H74939171040410
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon burst occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified arteriovenous fistula.A 4mm x 40mmx 135cm mustang balloon catheter was advanced for dilation.During the procedure, the balloon burst upon first inflation at 10 atmospheres for 2 minutes.The device was removed successfully and there were no fragments left inside the patient.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
D2b: pro code (product code) - fge, lit.G4: premarket / 510(k) # - k103751, k110122.Device evaluated by manufacturer: returned product consisted of a mustang.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was observed inside the balloon which is evidence of a device leak.A leak test identified a balloon pinhole located at the distal edge of the distal markerband.The rated burst pressure for this device as per specification is 24 atmospheres.A visual and tactile examination found no kinks or damage to the shaft and 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.No other issues were identified with the device.
Event or Problem Description
It was reported that balloon burst occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified arteriovenous fistula.A 4mm x 40mmx 135cm mustang balloon catheter was advanced for dilation.During the procedure, the balloon burst upon first inflation at 10 atmospheres for 2 minutes.The device was removed successfully and there were no fragments left inside the patient.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 18966456
• Report Number: 2124215-2024-17663
• Device Sequence Number: 6035579
• Product Code: FGE
• UDI-Device Identifier: 08714729793557
• UDI-Public: (01)08714729793557(17)260214(10)31046138
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 05/12/2025

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: 02/14/2026
• Device Model Number: H74939171040410
• Device Catalogue Number: H74939171040410
• Device Lot Number: 0031046138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 03/24/2024
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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: 55 YR
• Patient Sex: Male
• Patient Race: Asian