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

Model Number	M0061802220
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a contour ureteral stent was used during a ureteroscopy.During the procedure, it was noticed that the tip of the stent broke off.The procedure was completed with another of the same stent.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that a contour ureteral stent was used during a ureteroscopy.During the procedure, it was noticed that the tip of the stent broke off.The procedure was completed with another of the same stent.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of coil detachment of device or device component inside the patient.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of coil detachment of device or device component inside the patient.Block h11: the device was not returned for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Without a proper evaluation of the device or objective evidence, it remains unknown the most probable causes that could have contributed to the event.A review of the device history record (dhr) was performed.It was confirmed this device met manufacturing 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 coil detachment of device or device component 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.A similar complaint review was completed.There were no emerging trends identified that warrant further action.Based on a thorough review of the reported information, boston scientific has assigned an investigation conclusion code of cause not established.

• Brand Name: Contour
• 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: 50425863
• Report Number: 2124215-2026-45552
• Device Sequence Number: 18401733
• Product Code: FAD
• UDI-Device Identifier: 08714729058502
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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: M0061802220
• Device Catalogue Number: 180-222
• Device Lot Number: 0038946802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 08/25/2026
• Supplement Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 03/27/2026
• 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