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

Model Number	M0061802230
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a contour ureteral stent was implanted into the patient.A month later, following the procedure, a stent removal procedure was performed, and it was found that the stent's wall was encrusted.The stent was removed under intravenous anesthesia and successfully completed the procedure.There were no known patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a040501 captures the reportable event of stent calcified.
Additional Manufacturer Narrative
Block h6: device code a040501 captures the reportable event of stent calcified.Block b2, block b5, block d6a, block d6b, block e1, and block e3, have been updated based on the additional information received on august 24, 2025.
Event or Problem Description
It was reported that a contour ureteral stent was implanted into the patient.A month later, following the procedure, a stent removal procedure was performed, and it was found that the stent's wall was encrusted but was still able to drain.The stent was completely removed under intravenous anesthesia and successfully completed the procedure.There was no new stent implanted and there were no known patient complications reported.

• 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: 22893779
• Report Number: 2124215-2025-58513
• Device Sequence Number: 8984726
• Product Code: FAD
• UDI-Device Identifier: 08714729058533
• UDI-Public: (01)08714729058533(17)280113(10)35615195
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 06/29/2026

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: M0061802230
• Device Catalogue Number: 180-223
• Device Lot Number: 0035615195
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: 08/24/2025; 06/03/2026
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 09/17/2025; 06/29/2026
• Date Device Manufactured: 01/13/2025
• 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 Age: 39 YR
• Patient Sex: Female