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

Model Number	M0061802220
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a020503 captures the reportable event of seal compromised.
Event or Problem Description
It was reported that a contour ureteral stent was to be used in a transurethral stent placement procedure.During unpacking, it was observed that the inner package was damaged.The sterile barrier was reported to be compromised.The procedure was completed with another of the same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a020503 captures the reportable event of seal compromised.Block h11: investigation analysis upon receipt at our quality assurance laboratory, this contour ureteral stent underwent a thorough analysis.Visual analysis did not identify any damages to the returned device since the inner bag has the specific hole to retrieve the device.The positioner and the opened box were also returned, however, the suture was not returned.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.Based on the information available and analysis results, it was not possible to identify any evidence of either the alleged issue or any defect on the device.A conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that a contour ureteral stent was to be used in a transurethral stent placement procedure.During unpacking, it was observed that the inner package was damaged.The sterile barrier was reported to be compromised.The procedure was completed with another of the same device and there were no 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: 23589497
• Report Number: 2124215-2025-83667
• Device Sequence Number: 9859699
• Product Code: FAD
• UDI-Device Identifier: 08714729058502
• UDI-Public: (01)08714729058502(17)270717(10)34451779
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/15/2025

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: 0034451779
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2024
• 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 Age: 38 YR
• Patient Sex: Male
• Patient Weight: 68 KG