MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Contour VL?; stent, ureteral

Model Number	M0061801550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that, during stent insertion a contour was used prior to procedure.It was determined that it was broken in half and no longer be used.The procedure was completed via alternative device used.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that, during stent insertion a contour was used prior to procedure.It was determined that it was broken in half and no longer be used.The procedure was completed via alternative device used.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that, during stent insertion a contour was used prior to procedure.It was determined that it was broken in half and no longer be used.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.Block h11: the device was not returned for analysis; therefore, no physical of the product could be performed.However, the customer provided a photo in which the device appears to have the shaft detached approximately at the middle being able to confirm the reported issue.A review of the device history record (dhr) was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A risk review was completed and confirmed that the event of stent shaft break was defined in the risk documentation and is documented accordingly.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.Therefore, based on the available information, the most probable cause is adverse event related to procedure, since the reported adverse event is consistent with procedural factors and there is no evidence from the manufacturing review to indicate that the device contributed to the event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.Block h11: the contour stent was returned for analysis.During the inspection it was found that the stent shaft detached, which confirm the reported event.Based on the most relevant information of the complaint event description, device analysis and including the product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.A review of the device history record (dhr) was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A risk review was completed and confirmed that the event of stent shaft break was defined in the risk documentation and is documented accordingly.This event type has been accounted during product risk analysis to support acceptable risk benefits for the product.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on the event.Correction to block h6 evaluation method code, have been updated.

• 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: 25806651
• Report Number: 2124215-2026-37517
• Device Sequence Number: 9054944
• Product Code: FAD
• UDI-Device Identifier: 08714729058410
• UDI-Public: (01)08714729058410(17)281120(10)38019609
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2026

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: M0061801550
• Device Catalogue Number: M0061801550
• Device Lot Number: 0038019609
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2026
• Supplement Date Received by Manufacturer: 07/22/2026; 08/18/2026
• Initial Report FDA Received Date: 07/13/2026
• Supplement Report FDA Received Date: 08/18/2026; 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2025
• 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