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

Model Number	M0061801560
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a contour ureteral stent was used in a ureteral stent placement procedure in the ureter.During the procedure, the physician had difficulty placing the stent requiring multiple attempts, and it was noticed that a portion of the distal coil broke.It was reported that the broken fragment was very small and was left in the ureter alongside with another existing stent.A computed tomography scan (ct-scan) was performed, and the broken piece of stent was retrieved through cystoscope in a subsequent procedure.There was no information if a new stent was placed.There were no other patient complications and the patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: device code a0501 captures the reportable event of coil detached inside the patient.Patient code e2008 captures the reportable event of unretrieved fragment inside the patient.Impact code f23 captures the reportable event of unexpected medical intervention.

• 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: 50225891
• Report Number: 2124215-2026-43265
• Device Sequence Number: 10296956
• Product Code: FAD
• UDI-Device Identifier: 08714729067986
• UDI-Public: (01)08714729067986
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0061801560
• Device Catalogue Number: M0061801560
• 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: 07/15/2026
• Supplement Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/15/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 176 LB
• Patient Race: White