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

Model Number	M0061856140
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: device code a020503 captures the reportable event of packaging seal compromised.
Event or Problem Description
It was reported that a contour injection ureteral stent was to be used in a laser lithotripsy.During unpacking, it was noticed that the packaging was torn.It was reported that the product could be contaminated.The procedure was completed with another of the same device and there were no patient complications reported.

• Brand Name: CONTOUR? INJECTION STENT SET
• 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: 22719752
• Report Number: 2124215-2025-54213
• Device Sequence Number: 9169389
• Product Code: FAD
• UDI-Device Identifier: 08714729346166
• UDI-Public: (01)08714729346166(17)250726(10)32474852
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2025

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 Expiration Date: 07/26/2025
• Device Model Number: M0061856140
• Device Catalogue Number: M0061856140
• Device Lot Number: 0032474852
• 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: 07/14/2025
• Initial Report FDA Received Date: 08/05/2025
• Date Device Manufactured: 07/27/2023
• 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