MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONTOUR? SUREDRIVE?; STENT, URETERAL

Model Number	M0061458670
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a180104 captures the reportable event of foreign material present in device.
Event or Problem Description
It was reported that a contour ureteral stent was used stent placement procedure in the bladder and urethra.During procedure closure, it was noticed that there were orange pieces from the pusher.The procedure was successfully completed with this device.There were no patient complications reported.

• Brand Name: CONTOUR? SUREDRIVE?
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24103099
• Report Number: 2124215-2026-03305
• Device Sequence Number: 10259419
• Product Code: FAD
• UDI-Device Identifier: 08714729903222
• UDI-Public: (01)08714729903222(17)271202(10)37748691
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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: M0061458670
• Device Catalogue Number: M0061458670
• Device Lot Number: 0037748691
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 04/19/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• 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