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

Model Number	M0061802240
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a150207 captures the reportable event of stent difficult to remove, inside the patient.Note: this report is two of two complaints that pertain to the same event (mfr.Report # 2124215-2025-58879 and mfr.Report #.
Event or Problem Description
It was reported that the stent did not uncoil from the renal end during removal, which causes concern for patient safety.There was no information on when the problem was noticed, on what completed the procedure and on the condition of the patient following the procedure.

• 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: 22916807
• Report Number: 2124215-2025-58881
• Device Sequence Number: 18580762
• Product Code: FAD
• UDI-Device Identifier: 08714729058564
• UDI-Public: (01)08714729058564(17)270201(10)33344291
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

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: M0061802240
• Device Catalogue Number: 180-224
• Device Lot Number: 0033344291
• 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: 08/01/2025
• Initial Report FDA Received Date: 08/28/2025
• Date Device Manufactured: 02/02/2024
• 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: Unknown