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

Model Number	M0061458670
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Micturition Urgency (1871)
Date of Event	10/08/2022
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 right ureter performed on (b)(6) 2022.The patient underwent the study on (b)(6) 2022, as part of the u0652 double-j registry clinical study.Post procedure, on (b)(6) 2022, a planned stent removal procedure was performed.The stent was not difficult to remove and was removed successfully.Pain control was required.It was reported that on (b)(6) 2022, the patient experienced mild irritative mictional disorder and was given a treatment plan of allergic interstitial nephritis (ains) discontinuation and ongoing diuresis on (b)(6) 2022.The mild irritative mictional disorder was reported to have not been resolved.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
Medical device problem code e1304 captures the reportable event of urinary urgency.Impact code f2303 captures the reportable event of medication required.
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 right ureter performed on (b)(6), 2022.The patient underwent the study on (b)(6), 2022, as part of the u0652 double-j registry clinical study.Post procedure, on (b)(6), 2022, a planned stent removal procedure was performed.The stent was not difficult to remove and was removed successfully.Pain control was required.It was reported that on (b)(6), 2022, the patient experienced mild irritative mictional disorder and was given a treatment plan of allergic interstitial nephritis (ains) discontinuation and ongoing diuresis on (b)(6), 2022.The mild irritative mictional disorder was reported to have not been resolved.Additional information: 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 information: the stent was successfully removed on (b)(6), 2022.The adverse event experienced by the patient was mild irritative micturition disorder.
Additional Manufacturer Narrative
Block h6: medical device problem code e1304 captures the reportable event of urinary urgency.Impact code f2303 captures the reportable event of medication required.Block h11: block b5 and block d6b have been updated based on additional information received february 03, 2023.Imdrf patient code e1304 captures the reportable event of micturition urgency.Block a1 patient identifier has been corrected.

• 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: 16300688
• Report Number: 3005099803-2023-00368
• Device Sequence Number: 15151360
• Product Code: FAD
• UDI-Device Identifier: 08714729903222
• UDI-Public: 08714729903222
• 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,Followup
• Report Date (Section B): 02/28/2023

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: 03/29/2025
• Device Model Number: M0061458670
• Device Catalogue Number: 64441
• Device Lot Number: 0029660367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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: 53 YR
• Patient Sex: Male