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

Model Number	M0061802220
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf impact code f1001 captures the reportable event of aborted/cancelled procedure.
Event or Problem Description
It was reported that during insertion, the stent failed to advance to the kidney along with guidewire.The procedure was not completed due to this event and the patient condition following the procedure was stable.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of aborted/cancelled procedure.Block h11: the returned contour stent was analyzed, and a visual evaluation noted that the tip was torn, a functional test was performed, and it passed since a mandrel of 0.039 in was inserted into the stent to evaluate whether any resistance inside the device.However, no resistance was felt during the analysis performed and the mandrel was able to fully pass through the stent, which does not confirm the reported event "stent/delivery system difficult to advance".The suture was not returned.The analysis performed to the returned device; it is possible to conclude that this issue could be caused by operational factors.Based on the analysis results regarding the observed stent torn, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that during insertion, the stent failed to advance to the kidney along with guidewire.The procedure was not completed due to this event and the patient condition following the procedure was stable.

• 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: 22874907
• Report Number: 2124215-2025-58823
• Device Sequence Number: 18734707
• Product Code: FAD
• UDI-Device Identifier: 08714729058502
• UDI-Public: (01)08714729058502(17)270902(10)34760210
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 11/06/2025

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: 0034760210
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2024
• 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: Male