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

Model Number	M0061903230
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Incontinence (1928); Pain (1994); Urinary Incontinence (4572)
Date of Event	02/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report source: clinical study: (b)(6).(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
Note: this report is one of two complaints that pertain to the same event (mfr# 3005099803-2020-01713).It was reported to boston scientific corporation that a tria ureteral stent was used in a stent placement procedure for stone management for stones in the right and left kidneys performed on (b)(6) 2020 as part of the (b)(6) clinical study.On (b)(6) 2020, the tria ureteral stents were successfully implanted in the right and left ureters, and the patient was prescribed alpha blocker, anticholinergic, nsaids, and phenazopyridine at discharged.No issues were noted with the devices.According to the complainant, after the procedure on (b)(6) 2020, the patient had experienced urge incontinence and pain.On (b)(6) 2020, the stents were removed at home, due to urge incontinence and pain, without difficulty utilizing the stent retrieval line.The stents were removed, not per the initial plan, 3 days earlier than the intended plan.The patient was given an oral pain control.On (b)(6) 2020 the urge incontinence was considered resolved.On (b)(6) 2020 the pain was considered resolved.
Additional Manufacturer Narrative
Block g3: clinical study: u0652 double-j registry.Block h6: imdrf patient code e232402 captures the reportable event of urinary incontinence.Imdrf patient code e2330 captures the reportable event of pain.Block h11: block b5 has been updated based on additional information received on march 16, 2023.
Event or Problem Description
Note: this report is one of two complaints that pertain to the same event (mfr# 3005099803-2020-01713 and mfr# 3005099803-2020-01712).It was reported to boston scientific corporation that a tria ureteral stent was used in a stent placement procedure for stone management for stones in the right and left kidneys performed on (b)(6), 2020 as part of the u0652 double-j registry clinical study.On (b)(6), 2020, the tria ureteral stents were successfully implanted in the right and left ureters, and the patient was prescribed alpha blocker, anticholinergic, nsaids, and phenazopyridine at discharged.No issues were noted with the devices.According to the complainant, after the procedure on (b)(6), 2020, the patient had experienced urge incontinence and pain.On (b)(6), 2020, the stents were removed at home, due to urge incontinence and pain, without difficulty utilizing the stent retrieval line.The stents were removed, not per the initial plan, 3 days earlier than the intended plan.The patient was given an oral pain control.On (b)(6), 2020 the urge incontinence was considered resolved.On (b)(6), 2020 the pain was considered resolved.Additional information received on march 16, 2023, that the site updated the relationship to device to casual.

• Brand Name: TRIA SOFT
• 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: 9970207
• Report Number: 3005099803-2020-01712
• Device Sequence Number: 4483637
• Product Code: FAD
• UDI-Device Identifier: 08714729959908
• UDI-Public: 08714729959908
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K191609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2023

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: 10/06/2022
• Device Model Number: M0061903230
• Device Catalogue Number: 1983-02
• Device Lot Number: 0024550783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2019
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 78 KG