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

Model Number	M0061903320
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	11/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Study source: u0652 double-j.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a tria ureteral stent was implanted during a stent placement procedure for stone placement management and laser lithotripsy in the left kidney on (b)(6) 2020 as part of the u0652 double-j clinical study.Discharge medications included antibiotic, alpha blocker, anticholinergic, and phenazopyridine were given to the patient.On (b)(6) 2020, the patient experienced mild incomplete emptying.The patient had a catheter insertion and was hospitalized from (b)(6) 2020 to (b)(6) 2020.The adverse event was considered to be resolved as of november 27, 2020.
Additional Manufacturer Narrative
Block g3: study source: u0652 double-j.Block h6: patient problem code e1309 captures the reportable event of urinary retention.Impact code f08 captures the reportable event of hospitalization or prolonged hospitalization.Impact code f22 captures the reportable event of unexpected diagnostic intervention.Block h10: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a tria ureteral stent was implanted during a stent placement procedure for stone placement management and laser lithotripsy in the left kidney on (b)(6) 2020 as part of the u0652 double-j clinical study.Discharge medications included antibiotic, alpha blocker, anticholinergic, and phenazopyridine were given to the patient.On (b)(6) 2020, the patient experienced mild incomplete emptying.The patient had a catheter insertion and was hospitalized from (b)(6) 2020 to (b)(6) 2020.The adverse event was considered to be resolved as of november 27, 2020.Additional information received on 28jun2022 stating that the adverse event of mild incomplete emptying has been inactivated since it was reported as a duplicate.
Event or Problem Description
It was reported to boston scientific corporation that a tria ureteral stent was implanted during a stent placement procedure for stone placement management and laser lithotripsy in the left kidney on (b)(6) 2020 as part of the u0652 double-j clinical study.Discharge medications included antibiotic, alpha blocker, anticholinergic, and phenazopyridine were given to the patient.On (b)(6) 2020, the patient experienced mild incomplete emptying.The patient had a catheter insertion and was hospitalized from (b)(6) 2020 to (b)(6) 2020.The adverse event was considered to be resolved as of (b)(6) 2020.Additional information received on 28jun2022 stating that the adverse event of mild incomplete emptying has been inactivated since it was reported as a duplicate.Additional information received on september 13, 2022 stating that the relationship of the device and the adverse event of left flank pain was not related.Independent medical reviewer adjudicated study device as possibly related.
Additional Manufacturer Narrative
Block g3: study source: u0652 double-j block h6: patient problem code e1309 captures the reportable event of urinary retention.Impact code f08 captures the reportable event of hospitalization or prolonged hospitalization.Impact code f22 captures the reportable event of unexpected diagnostic intervention.Block h10: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.Bloch h11: additional information block b5 have been updated based on the additional information received on september 13, 2022.

• 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: 14789749
• Report Number: 3005099803-2022-03382
• Device Sequence Number: 12026549
• Product Code: FAD
• UDI-Device Identifier: 08714729959939
• UDI-Public: 08714729959939
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K191609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 10/06/2022

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: 10/01/2022
• Device Model Number: M0061903320
• Device Catalogue Number: 1983-02
• Device Lot Number: 0024532589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 06/28/2022; 09/13/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 07/22/2022; 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2019
• 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: 64 YR
• Patient Sex: Female