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

Model Number	M006180156190
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the insertion of a rigid ureteroscopy procedure, the device was found broken.It was noted that the stent was broken into two pieces along the shaft.The procedure was completed with another of the same stent and there were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Imdrf device code a0401 captures the reportable event of stent shaft broken.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft broken.Block h11: the contour ureteral stent was not returned; however, one picture attached showed one opened box and the device was not visible in the photo.No other problems with the device were noted.The reported event of stent shaft break was not confirmed.Based on the analysis, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.Additionally, without proper evaluation of the device or objective evidence, it remains unknown the most probable causes that could have contributed to the event.Therefore, this event is being assigned the conclusion code of cause not established since the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.
Event or Problem Description
During the insertion of a rigid ureteroscopy procedure, the device was found broken.It was noted that the stent was broken into two pieces along the shaft.The procedure was completed with another of the same stent and there were no patient complications reported as a result of this event.
Event or Problem Description
During the insertion of a rigid ureteroscopy procedure, the device was found broken.It was noted that the stent was broken into two pieces along the shaft.The procedure was completed with another of the same stent and there were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft broken.Block h11: the contour ureteral stent was returned with ureteral axxcess catheter and zipwire.Media inspection was performed, and a picture was attached in the complaint record.It showed one contour vl opened box, the device was not visible in the photo.Based on the visual and microscopic inspection, the stent was returned with the positioner, the zipwire and with open end catheter for analysis, however the suture was not returned.The device was inspected under magnification, and it was possible to see that the stent shaft detached in two parts.The reported event was confirmed.With all the available information, boston scientific concludes that the reported event of stent shaft break was confirmed.It is possible to conclude that this problem could be caused by operational factors.The retrieval line may be removed before placement at the physicians discretion.If the retrieval line gets entangled in the coil and is removed using excess force, the stent can get detached or separated during the preparation affecting the performance of the device.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on the event.

• 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; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20551099
• Report Number: 2124215-2024-65085
• Device Sequence Number: 21073169
• Product Code: FAD
• UDI-Device Identifier: 08714729765837
• UDI-Public: (01)08714729765837(17)260918(10)33170122
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup
• Report Date (Section B): 05/27/2025

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: 09/18/2026
• Device Model Number: M006180156190
• Device Catalogue Number: M006180156190
• Device Lot Number: 0033170122
• 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: 10/02/2024
• Supplement Date Received by Manufacturer: 11/01/2024; 05/05/2025
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 11/26/2024; 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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: Male