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

Model Number	M0061801560
Medical Device Problem Codes	Nonstandard Device (1420); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a contour ureteral stent was used in a flexible ureteroscopy & insertion of ureteric stent in the kidney, ureter and bladder.During the procedure, when the guidewire was removed, it got stuck, causing for the stent to recoil.The procedure was completed with another same device and there were no patient complications reported.A picture provided by the customer showed that the stent was buckled.
Additional Manufacturer Narrative
Block h6: device code a040601 captures the reportable event of stent buckled accordion inside the patient.
Additional Manufacturer Narrative
Device code a040601 captures the reportable event of stent buckled accordion inside the patient.Investigation analysis: upon receipt at our quality assurance laboratory, this contour stent underwent a thorough analysis.Visual analysis identified that the stent bladder coil was totally buckled and torn, also, the two holes were torn.The reported event of stent buckled material was confirmed.Based on the information available and analysis results, it is possible to conclude that the issue could be caused by operational factors.The retrieval line may be removed before placement at the physician's discretion.If the retrieval line gets entangled in the bladder coil and is removed using excess force, the stent could get torn during the preparation affecting the performance of the device.Additionally, if the positioner is advanced with excess force over the guidewire the stent can get buckled/accordioned resulting in a difficulty/unable to advance 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 flexible ureteroscopy & insertion of ureteric stent in the kidney, ureter and bladder.During the procedure, when the guidewire was removed, it got stuck, causing for the stent to recoil.The procedure was completed with another same device and there were no patient complications reported.A picture provided by the customer showed that the stent was buckled.

• Brand Name: CONTOUR VL?
• 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: 23337464
• Report Number: 2124215-2025-74438
• Device Sequence Number: 9471003
• Product Code: FAD
• UDI-Device Identifier: 08714729067986
• UDI-Public: (01)08714729067986(17)280218(10)35880809
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 12/19/2025

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: M0061801560
• Device Catalogue Number: M0061801560
• Device Lot Number: 0035880809
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• 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