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

Model Number	M0061802230
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation, the nurse found that the ureteral stent was fractured.The procedure was completed with another of the same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation results of stent shaft break.
Event or Problem Description
It was reported that during preparation, the nurse found that the ureteral stent was fractured.The procedure was completed with another of the same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation results of stent shaft break.Block h11: the contour ureteral stent was not returned for analysis.The reported event of stent shaft break will not be confirmed.There is no evidence from the manufacturing review to indicate that the device malfunctioned because of a process related defect.The most probable cause of the reported issue cannot be established due to lack of evidence.Additionally, without a proper evaluation of the device or objective evidence, it remains unknown the most probable causes that could have contributed to the event.Therefore, this complaint is assigned an investigation 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.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation results of stent shaft break.Block h11: the contour ureteral stent was returned for analysis.The reported event of stent shaft break is confirmed.During the visual, magnification, and media inspection, it was found that the stent shaft detached and the stent coil bladder with a suture hole torn.Regarding to the analysis performed to the returned device, it is possible to conclude that this 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 can get detached or separated and torn 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 preparation and the device had no influence on the event.
Event or Problem Description
It was reported that during preparation, the nurse found that the ureteral stent was fractured.The procedure was completed with another of the same device and there were no patient complications reported.

• 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: 21318082
• Report Number: 2124215-2025-05596
• Device Sequence Number: 8696380
• Product Code: FAD
• UDI-Device Identifier: 08714729058533
• UDI-Public: (01)08714729058533(17)270103(10)33138820
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2025

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: M0061802230
• Device Catalogue Number: 180-223
• Device Lot Number: 0033138820
• 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: 01/14/2025
• Supplement Date Received by Manufacturer: 02/11/2025; 04/02/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/07/2025; 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• 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