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

Model Number	H74939171060870
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon burst occurred.The stenosed target lesion was located in the radial artyery.A 6.0 x 80, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured after being inflated two to three times.The device was removed and the procedure was completed using with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
D2b: fge, lit.G4: pma/510(k) #: k141521, k141597.
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.G4: pma/510(k) #: k141521, k141597.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.Blood present in balloon.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 20mm distal from the proximal 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.
Event or Problem Description
It was reported that balloon burst occurred.The stenosed target lesion was located in the radial artery.A 6.0 x 80, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured after being inflated two to three times.The device was removed, and the procedure was completed using with another of the same device.There were no patient complications as a result of this event.

• 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: 21589880
• Report Number: 2124215-2025-15430
• Device Sequence Number: 21064220
• Product Code: FGE
• UDI-Device Identifier: 08714729793854
• UDI-Public: (01)08714729793854(17)270516(10)34043590
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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: H74939171060870
• Device Catalogue Number: H74939171060870
• Device Lot Number: 0034043590
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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 Age: 63 YR
• Patient Sex: Male