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

Model Number M0061458670

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Micturition Urgency (1871)

Event Date 10/08/2022

Event Type  Injury  

Event 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.

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 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.

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
• Type of Device: 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
• MDR Text Key: 308822547
• Report Number: 3005099803-2023-00368
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729903222
• UDI-Public: 08714729903222
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K974541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 01/12/2023
• Initial Date FDA Received: 02/03/2023
• Supplement Dates Manufacturer Received: 02/03/2023
• Supplement Dates FDA Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male