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

Model Number	H74939171100870
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 60% stenosed target lesion was located in the moderately tortuous and moderately calcified radial artery.A 10.0 x 80, 75 cm mustang balloon was selected for use in a percutaneous transluminal angioplasty.During the second inflation at 8 atmospheres for 30 seconds, the balloon ruptured inside the patient's body.The device was removed, and 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) #: k141521, k141597.E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 60% stenosed target lesion was located in the moderately tortuous and moderately calcified radial artery.A 10.0 x 80, 75cm mustang balloon was selected for use in a percutaneous transluminal angioplasty.During the second inflation at 8 atmospheres for 30 seconds, the balloon ruptured inside the patient's body.The device was removed, and 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 e1 - initial reporter phone: (b)(6).E1 - initial reporter email: added g4 - premarket / 510(k) #: k141521, k141597.Device evaluated by mfr: the device was returned for evaluation.A visual examination of the returned device found that the balloon had been inflated and was not refolded.A circumferential tear was noted approximately 10mm distal from the proximal balloon bond.The remainder of the balloon was pulled in a distal direction over the distal tip.A longitudinal tear was noted on the part of balloon that was pulled over the distal tip.A visual examination identified that the distal markerband was noted to be damage.A visual and tactile examination found the shaft of the device to have completely detached at approximately 710mm distal from the distal end of the strain relief.The shaft was noted to be stretched, and multiple shaft kinks were noted to be damaged.The investigator was unable to view the tip fully as the balloon had been pulled over it.No other issues were identified during the product analysis.
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit e1 - initial reporter phone: (b)(6).G4 - premarket / 510(k) #: k141521, k141597 device evaluated by mfr: the device was returned for evaluation.A visual examination of the returned device found that the balloon had been inflated and was not refolded.A circumferential tear was noted approximately 10mm distal from the proximal balloon bond.The remainder of the balloon was pulled in a distal direction over the distal tip.A longitudinal tear was noted on the part of balloon that was pulled over the distal tip.A visual examination identified that the distal markerband was noted to be damage.A visual and tactile examination found the shaft of the device to have completely detached at approximately 710mm distal from the distal end of the strain relief.The shaft was noted to be stretched, and multiple shaft kinks were noted to be damaged.The investigator was unable to view the tip fully as the balloon had been pulled over it.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 60% stenosed target lesion was located in the moderately tortuous and moderately calcified radial artery.A 10.0 x 80, 75cm mustang balloon was selected for use in a percutaneous transluminal angioplasty.During the second inflation at 8 atmospheres for 30 seconds, the balloon ruptured inside the patient's body.The device was removed, and the procedure was completed 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: 22737351
• Report Number: 2124215-2025-54734
• Device Sequence Number: 15235170
• Product Code: FGE
• UDI-Device Identifier: 08714729794332
• UDI-Public: (01)08714729794332(17)271220(10)35528248
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2025

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: H74939171100870
• Device Catalogue Number: H74939171100870
• Device Lot Number: 0035528248
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 10/03/2025; 11/04/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 10/27/2025; 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2024
• 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: 71 YR
• Patient Sex: Female