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

Model Number	M0061458670
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of coil detached inside the patient.Device code a150207 captures the reportable event of stent difficult to remove.
Event or Problem Description
It was reported that a contour ureteral stent was implanted into the patient.Post procedure, a stent removal was performed and during the procedure, there was difficulty in removing the stent and it was noticed that the bladder coil broke.There was no information on what device have completed the procedure.The patient had experienced bleeding during the procedure.No other complications reported.
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of coil detached inside the patient.Device code a150207 captures the reportable event of stent difficult to remove.Block h11: investigation analysis: upon receipt at our quality assurance laboratory, this contour ureteral stent underwent a thorough analysis.Visual inspection of the returned device revealed that the stent bladder coil was detached, and the stent was calcified.The suture was not returned for analysis.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.Based on the information available and analysis results, 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/separated during the preparation affecting the performance of the device and it could affect the stent remove from patient.Additionally, minor hemorrhage and stone calcification are potential complication that may be associated with the use of the device, and minor injury/illness /impairment is a subsequent event of the primary anticipated event.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 implanted into the patient.Post procedure, a stent removal was performed and during the procedure, there was difficulty in removing the stent and it was noticed that the bladder coil broke.There was no information on what device have completed the procedure.The patient had experienced bleeding during the procedure.No other complications reported.

• Brand Name: CONTOUR? SUREDRIVE?
• 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: 22745836
• Report Number: 2124215-2025-54961
• Device Sequence Number: 4565405
• Product Code: FAD
• UDI-Device Identifier: 08714729903222
• UDI-Public: (01)08714729903222(17)270708(10)35345413
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: M0061458670
• Device Catalogue Number: M0061458670
• Device Lot Number: 0035345413
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• 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 Age: 79 YR
• Patient Sex: Male