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

Model Number	M006180156010
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a040601 captures the reportable event of stent buckled material inside the patient.
Event or Problem Description
It was reported that a contour ureteral stent was used in a ureteroscopic lithotripsy procedure in the ureter.During insertion, when the stent was inserted through the wire and positioner, it was noticed that the stent was wrinkled.The procedure was completed with another of the same device and there were no patient complications reported.
Event or Problem Description
It was reported that a contour ureteral stent was used in a ureteroscopic lithotripsy procedure in the ureter.During insertion, when the stent was inserted through the wire and positioner, it was noticed that the stent was wrinkled.The procedure was completed with another of the same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a040601 captures the reportable event of stent buckled material inside the patient.Block d6a has been corrected.Block h11: investigation analysis.Upon receipt at our quality assurance laboratory, this contour ureteral stent underwent a thorough analysis.Visual analysis did not identify any damages to the returned device.Functional evaluation revealed that a mandrel of 0.039 was inserted into the stent to evaluate if some resistance is felt inside the device, however, no resistance was felt during the analysis performed and the mandrel was able to fully pass through the stent.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.Based on the information available and analysis results, the reported allegation of stent buckled material and stent/delivery system difficult to advance was not confirmed.A conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that a contour ureteral stent was used in a ureteroscopic lithotripsy procedure in the ureter.During insertion, when the stent was inserted through the wire and positioner, it was noticed that the stent was wrinkled.The procedure was completed with another of the same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a040601 captures the reportable event of stent buckled material inside the patient.Block e1 initial reporter email, has been updated based on the additional information provided on december 08, 2025.

• Brand Name: CONTOUR VL
• 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: 23753753
• Report Number: 2124215-2025-89766
• Device Sequence Number: 5928265
• Product Code: FAD
• UDI-Device Identifier: 08714729067993
• UDI-Public: (01)08714729067993(17)280211(10)33516912
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2026

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: M006180156010
• Device Catalogue Number: 180-156-01
• Device Lot Number: 0033516912
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 12/08/2025; 01/05/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/02/2026; 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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: Male