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

Model Number	M0061903330
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a tria ureteral stent was used in a stent placement study procedure in the right and left ureter performed on (b)(6) 2020 as part of the u0652 double-j registry clinical study.On (b)(6) 2020, the tria ureteral stent was successfully placed in the right ureter under fluoroscopy.No issues were reported with the device during placement.Discharge medications included alpha blocker, anticholinergic, and phenazopyridine.On (b)(6) 2020, the left side stent was explanted and on (b)(6) 2020, the right side stent was explanted with no associated adverse event.No issues were noted with the devices during stent removal.On (b)(6) 2020, the patient experienced mild urinary tract infection possibly related to the stent removal procedure.Augmentin, unasyn, acetaminophen medication were given to the patient.The adverse event was reported to be resolve on (b)(6) 2020.The relationship between the device and the adverse event was reportedly not related.There were no new device implanted.
Additional Manufacturer Narrative
Report source: study: u0652 double-j registry clinical study.(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 medwatch will be filed.

• 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: 15089593
• Report Number: 3005099803-2022-03889
• Device Sequence Number: 4055738
• Product Code: FAD
• UDI-Device Identifier: 08714729959946
• UDI-Public: 08714729959946
• 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: 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
• Report Date (Section B): 07/22/2022

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: M0061903330
• Device Catalogue Number: 1983-02
• Device Lot Number: 0024532590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 07/22/2022
• 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: 63 YR
• Patient Sex: Male