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

Model Number	H74937912519150
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code (product code): nin.G4: premarket / 510(k) #: k162404, p060006.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the renal artery.A 5.0mmx19mmx150cm express sd renal/biliary stent was used in the percutaneous transluminal angioplasty.However, during the procedure, it was noted that the stent strut was damaged.The procedure was completed with a different device.No patient complications were reported, and the patient condition was stable.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the renal artery.A 5.0mmx19mmx150cm express sd renal/biliary stent was used in the percutaneous transluminal angioplasty.However, during the procedure, it was noted that the stent strut was damaged.The procedure was completed with a different device.No patient complications were reported, and the patient condition was stable.
Additional Manufacturer Narrative
D2b - pro code (product code): nin.G4 - premarket / 510(k) #: k152607, k162404, p060006.Device evaluated by mfr: the express sd balloon catheter was returned to our post market quality assurance laboratory.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the stent is partially deployed.Microscopic examination revealed no additional damages.There is contrast present inside the inflation lumen.Inspection of the remainder of the device presented no damage or irregularities.Product analysis found that the stent is partially deployed.

• 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: 21207957
• Report Number: 2124215-2025-02843
• Device Sequence Number: 8070829
• Product Code: FGE
• UDI-Device Identifier: 08714729390473
• UDI-Public: (01)08714729390473(17)260403(10)31366739
• 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): 04/25/2025

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 Expiration Date: 04/03/2026
• Device Model Number: H74937912519150
• Device Catalogue Number: H74937912519150
• Device Lot Number: 0031366739
• 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: 12/30/2024
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2023
• 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: 66 YR
• Patient Sex: Male