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

Model Number	H74937911415150
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
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 stent damage occurred.A 4.0mmx15mmx150cm express sd renal/biliary stent was selected for use during a percutaneous transluminal angioplasty procedure.The stenosed target lesion was located in the renal vessel.During the procedure, damage was noted to the stent strut.The procedure was completed with a different device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that stent damage occurred.A 4.0mmx15mmx150cm express sd renal/biliary stent was selected for use during a percutaneous transluminal angioplasty procedure.The stenosed target lesion was located in the renal vessel.During the procedure, damage was noted to the stent strut.The procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D2b: pro code (product code): fge, nin.G4: premarket / 510(k) #: k152607, k162404, p060006.Device evaluated by mfr: the express sd was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed a kink 24.2cm from the tip.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no damage or irregularities.Product analysis could not confirm the reported damage to the stent.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23864796
• Report Number: 2124215-2025-92297
• Device Sequence Number: 14785243
• Product Code: FGE
• UDI-Device Identifier: 08714729390374
• UDI-Public: (01)08714729390374(17)251212(10)30704340
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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 Expiration Date: 12/12/2025
• Device Model Number: H74937911415150
• Device Catalogue Number: H74937911415150
• Device Lot Number: 0030704340
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• 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: 68 YR
• Patient Sex: Female