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

Model Number	H74939171062070
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.G4 - premarket / 510(k) #: k103751, k110122, k141521.Device analysis findings: upon receipt at our post market quality assurance laboratory, 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 approximately 4mm distal of the distal markerband.The rated burst pressure for this device as per specification is 22 atmospheres.The device cannot be advanced through a sheath due to the balloon pinhole.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.This concludes the product analysis.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a review of the mustang device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unintended use error caused or contributed to event.
Event or Problem Description
Reportable based on device analysis completed on 01apr2026.It was reported that difficulty advancing occurred.A 6.0 x 200, 75cm mustang was selected for use.However, during the procedure, it was noted that significant resistance was felt when advancing into the non-boston scientific sheath.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.However, device analysis revealed a balloon pinhole located approximately 4mm distal of the distal markerband.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24923378
• Report Number: 2124215-2026-21163
• Device Sequence Number: 21117849
• Product Code: FGE
• UDI-Device Identifier: 08714729794509
• UDI-Public: (01)08714729794509(17)280625(10)36841659
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 04/20/2026

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: H74939171062070
• Device Catalogue Number: H74939171062070
• Device Lot Number: 0036841659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH - TERUMO, 7FR
• Patient Age: 68 YR
• Patient Sex: Female