MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Contour; stent, ureteral

Model Number	M0061802210
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: device code a0414 captures the reportable event of stent torn material inside the patient.
Event or Problem Description
It was reported that a contour ureteral stent was used in a ureteroscopic lithotripsy procedure in the ureter.During procedure and inside the patient, the stent was found unusable due to suspected coating detachment.The procedure was completed with another of the same device and there were no patient complications reported.
Event or Problem Description
It was reported that a contour ureteral stent was used in a ureteroscopic lithotripsy procedure in the ureter.During procedure and inside the patient, the stent was found unusable due to suspected coating detachment.The procedure was completed with another of the same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: device code a0414 captures the reportable event of stent torn material inside the patient.Block h11: investigation analysis the returned contour ureteral stent was analyzed, and during the inspection no damage was found, which did not confirm the reported event.Based on the most relevant information, the analysis performed to the returned device, it is possible to conclude that this problem could be caused by operational factors.Based on the most relevant information, after visual, microscope and functional inspections in the complaint device, it was not possible to identify any evidence of either the alleged problem or any defect on the device.Also, the evidence from the product record review did not identify a potential product quality issue or new patient harm.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.A risk review was completed and confirmed that the event was defined in the risk documentation.Based on the results of the device evaluation, an investigation conclusion code of device problem excluded was assigned to this investigation.

• 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: 24416510
• Report Number: 2124215-2026-09863
• Device Sequence Number: 13391309
• Product Code: FAD
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2026

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: M0061802210
• Device Catalogue Number: 180-221
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/16/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/06/2026; 07/13/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 04/02/2026; 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male