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

Model Number	H74939171120470
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for detailed analysis.Upon visual inspection, it was noted that the balloon was not folded, suggesting that the balloon had been exposed to positive pressure.According to the mustang specification, the rated burst pressure for this device is 14 atmospheres.The returned device was connected to an encore inflation unit.During testing, positive pressure was applied, and leakage of di water was observed from a pinhole in the balloon, located approximately 18mm proximal to the distal markerband.A thorough visual inspection of the markerbands revealed no abnormalities.Additionally, a combined visual and tactile examination of the shaft identified no kinks or damage.Similarly, a visual and tactile assessment of the tip confirmed the absence of any damage.
Event or Problem Description
Repotable based on the device analysis completed on 29apr2025.It was reported that the balloon failed to inflate.A 12.0 x 40, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon expansion did not function as intended.Attempts were made to inflate the balloon two to three times at approximately 12 atmospheres of pressure.There were no patient complication as a result of the event.However, 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: 22085014
• Report Number: 2124215-2025-33894
• Device Sequence Number: 7866341
• Product Code: LIT
• UDI-Device Identifier: 08714729793441
• UDI-Public: (01)08714729793441(17)271122(10)35342421
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K141597
• 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): 05/26/2025

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: H74939171120470
• Device Catalogue Number: H74939171120470
• Device Lot Number: 0035342421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 05/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2024
• 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