MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS SD RENAL/BILIARY; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	H74937912618150
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Insert (1316); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): fge, nin.G4 - premarket / 510(k) #: k152607, k162404, p060006.
Event or Problem Description
It was reported that device entrapment occurred.The 76% stenosed target lesion was located in the moderately tortuous and moderately calcified renal artery.A 6.0mm x 18mm x 150cm express sd renal/biliary stent balloon expandable was selected for use.During the procedure, the express sd renal/biliary device was difficult to load onto the 0.014" non-boston scientific guidewire and could not be fully advanced through the mach 1 guide catheter.The express sd renal/biliary became stuck on the guidewire, requiring both devices to be removed simultaneously.The renal artery was then re-wired, and the physician elected to balloon the lesion with a sterling balloon to complete the procedure.There were no patient complications as a result of this event.

• Brand Name: EXPRESS SD RENAL/BILIARY
• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 25166443
• Report Number: 2124215-2026-26018
• Device Sequence Number: 21451149
• Product Code: FGE
• UDI-Device Identifier: 08714729484844
• UDI-Public: (01)08714729484844(17)270117(10)33233665
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K152607
• 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): 07/16/2026

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: H74937912618150
• Device Catalogue Number: H74937912618150
• Device Lot Number: 0033233665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2024
• 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