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

Model Number	M0061802220
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Fever (1858); Pain (1994)
Date of Event	04/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf patient code e230101 captures the reportable event of pain.Imdrf patient code e2330 captures the reportable event of fever.Imdrf device code a010402 captures the reportable event of stent migration.
Event or Problem Description
It was reported to boston scientific corporation as a preventive treatment of closed pyelitis, a contour ureteral stent was implanted in the left kidney to ensure free outflow on (b)(6) 2025.Approximately 12 hours post-procedure, the patient woke up to extreme pain in the flank, ureter, and bladder.Pain was experienced despite the prescribed medication of advil of 1g every 4 hrs.And oxycodone 10mg as needed.The patient's temperature reached 38.8, and superficial breathing due to pain from abdominal movements was experienced.On (b)(6) 2025, the patient was sent to the emergency room, and ct-scan was taken, which showed that the stent was dislocated.The stent migrated down to the ureter and the other half was in the bladder.A procedure was performed the same day to reposition the stent.No further patient complications reported.
Event or Problem Description
It was reported to boston scientific corporation as a preventive treatment of closed pyelitis, a contour ureteral stent was implanted in the left kidney to ensure free outflow on (b)(6) 2025.Approximately 12 hours post-procedure, the patient woke up to extreme pain in the flank, ureter, and bladder.Pain was experienced despite the prescribed medication of advil of 1g every 4 hrs.And oxycodone 10mg as needed.The patient's temperature reached 38.8, and superficial breathing due to pain from abdominal movements was experienced.On (b)(6) 2025, the patient was sent to the emergency room, and ct-scan was taken, which showed that the stent was dislocated.The stent migrated down to the ureter and the other half was in the bladder.A procedure was performed the same day to reposition the stent.No further patient complications reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a010402 captures the reportable investigation results of stent migration.Imdrf patient code e230101 captures the reportable investigation results of pain.Imdrf patient code e2330 captures the reportable investigation results of fever.Block h11: correction to block h6: imdrf impact code f08 captures the reportable investigation results of hospitalization or prolonged hospitalization.Correction to block h6: imdrf impact code f1901 captures the reportable investigation results of additional surgery.The contour ureteral stent was returned with the pouch for analysis.However, the suture did not return.During the visual and device inspection, under magnification, the stent was found with the renal coil bent.Regarding to the analysis performed to the returned device, it is possible to conclude that this issue could be caused by operational factors.Some manipulation during the procedure could have caused the bent on the device.For this reason, it would be assigned with the code of as adverse event related to procedure.The reported stent migration could not be confirmed since the device cannot be functionally evaluated with respect to anatomical or procedural factors encountered during the procedure.Therefore, it remains unknown that the probable cause that could have contributed to the event.For that reason, the reported event will be documented as cause not established.The reported pain and fever are anticipated in the risk documentation.The instructions for use mentions pain or discomfort as potential complications that may be associated with the use of the device.Consequently, these events are assigned with the most probable cause classification of known inherent risk of device, which indicates that the reported adverse events are known and documented in the labeling.Therefore, this complaint is assigned an investigation conclusion code of cause not established, since the investigation findings does not lead to a clear conclusion about the cause of the reported adverse event.

• 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: 22032201
• Report Number: 2124215-2025-30475
• Device Sequence Number: 18512760
• Product Code: FAD
• UDI-Device Identifier: 08714729058502
• UDI-Public: (01)08714729058502(17)270904(10)34777361
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0061802220
• Device Catalogue Number: 180-222
• Device Lot Number: 0034777361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female