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

Model Number	M0061458660
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Hematuria (2558)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a contour ureteral stent was used in a stent placement procedure for stone management; laser lithotripsy in the left ureter performed on (b)(6) 2022, as part of the u0652 double-j registry clinical study.(b)(6) 2022, a planned stent removal procedure was performed.The stent was not difficult to remove and was removed successfully.Pain control was not required.It was reported that the patient experienced mild hematuria and mild left ureteral pain and was prescribed with ketoprofen for 48 hours as medication for the adverse events.The mild hematuria and mild ureteral pain were reported to have been resolved on (b)(6) 2022.In the physician's assessment, the relationship between the procedure and the event is possibly related, and the relationship between the device and the event is possibly related.
Additional Manufacturer Narrative
Study: u0652 double-j registry clinical study.Patient code e2330 captures the reportable event of pain.Patient code e1302 captures the reportable event of hematuria.Impact code f2303 captures the reportable event of medication required.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16300506
• Report Number: 3005099803-2023-00366
• Device Sequence Number: 6767203
• Product Code: FAD
• UDI-Device Identifier: 08714729903215
• UDI-Public: 08714729903215
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/27/2024
• Device Model Number: M0061458660
• Device Catalogue Number: 64441
• Device Lot Number: 0027729531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2021
• 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: 61 YR
• Patient Sex: Female