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

Model Number M0061903320

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

Patient Problem Urinary Retention (2119)

Event Date 11/25/2020

Event Type  Injury  

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 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.

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 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 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.

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
• 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: 14789749
• MDR Text Key: 295050906
• Report Number: 3005099803-2022-03382
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729959939
• UDI-Public: 08714729959939
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/23/2022
• Supplement Dates Manufacturer Received: 06/28/2022; 09/13/2022
• Supplement Dates FDA Received: 07/22/2022; 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2019
• 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: 64 YR
• Patient Sex: Female