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

Model Number	M0061802320
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a contour ureteral stent was used in a stent placement procedure.During the procedure, it was noticed that the distal end of the stent was extruded and could not be advanced into position.The procedure was not completed due to this event.There were no patient complications reported.A media was provided by the customer showed that the stent was torn and buckled.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.
Additional Manufacturer Narrative
Block e1: initial reporter address 1 (b)(6).Block h6: device code a040601 captures the reportable event of stent buckled material inside the patient.Device code a0414 captures the reportable event of stent torn material inside the patient.Impact code f1001 captures the reportable event of cancelled/rescheduled procedure.
Additional Manufacturer Narrative
Block e1: (b)(6).Block h6: device code a040601 captures the reportable event of stent buckled material inside the patient.Device code a0414 captures the reportable event of stent torn material inside the patient.Impact code f1001 captures the reportable event of cancelled/rescheduled procedure.Block h11: investigation analysis- upon receipt at our quality assurance laboratory, this contour ureteral stent underwent a thorough analysis.Visual analysis of the returned device identified that the stent bladder coil was buckled and torn.The positioner was also 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 is possible to conclude that this issue could be caused by operational factors.If the positioner is advanced with excess force over the guidewire, the stent could get buckled/accordioned and torn resulting in a difficulty/unable to advance or position the stent to the target site.A conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that a contour ureteral stent was used in a stent placement procedure.During the procedure, it was noticed that the distal end of the stent was extruded and could not be advanced into position.The procedure was not completed due to this event.There were no patient complications reported.A media was provided by the customer showed that the stent was torn and buckled.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.

• 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: 23662907
• Report Number: 2124215-2025-87161
• Device Sequence Number: 21130538
• Product Code: FAD
• UDI-Device Identifier: 08714729058687
• UDI-Public: (01)08714729058687(17)270216(10)33446074
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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,Followup
• Report Date (Section B): 02/26/2026

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: M0061802320
• Device Catalogue Number: 180-232
• Device Lot Number: 0033446074
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2024
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 54 KG