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

Model Number	H74939171070810
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code):fge, lit.G4 - premarket / 510(k) #:k141521, k141597.
Event or Problem Description
It was reported that balloon deflation issue occurred.A 7.0 x 80, 135cm mustang balloon catheter was selected for use in a superficial femoral artery angioplasty.During the procedure, balloon was inserted and inflated.Upon deflation with inflator, it would not be deflated.A syringe was used to pull negative to get it to deflate in order to remove it through the sheath from body.The same device was used to complete the procedure.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon deflation issue occurred.A 7.0 x 80, 135cm mustang balloon catheter was selected for use in a superficial femoral artery angioplasty.During the procedure, balloon was inserted and inflated.Upon deflation with inflator, it would not be deflated.A syringe was used to pull negative to get it to deflate in order to remove it through the sheath from body.The same device was used to complete the procedure.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.Device evaluated by mfr: the mustang device was returned for evaluation.A visual examination identified that the balloon was not folded, which indicates that the device was subjected to positive pressure.A leak test was carried out and the balloon was inflated to its rated burst pressure for 30 seconds using deionized water and digital timer without issue.A vacuum was then applied and the and the balloon deflated fully in 39 seconds.The deflation time was verified using digital timer.As per mustang specification, the deflation time from rated burst pressure must be less than or equals to 60 seconds.The balloon was inflated to its rated burst pressure and deflated on three more occasions with no leaks noted in the device.The times were measured at 37, 35, 34 seconds.The inflation device was verified at 20 atmospheres before and after use with a calibrated pressure gauge.A visual and tactile examination found multiple shaft kinks and stretching was noted along the length of the shaft.No issues were noted with the tip of the device.A visual examination found no issue with the markerbands.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
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23413667
• Report Number: 2124215-2025-76121
• Device Sequence Number: 21065112
• Product Code: FGE
• UDI-Device Identifier: 08714729794288
• UDI-Public: (01)08714729794288(17)280221(10)35906686
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: H74939171070810
• Device Catalogue Number: H74939171070810
• Device Lot Number: 0035906686
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2025
• 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