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

Model Number	M0061903310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Hematuria (2558); Dysuria (2684)
Date of Event	05/28/2022
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 indicated for stone management; laser lithotripsy in left ureter performed on (b)(6) 2022 as part of the u0652 double-j registry clinical study.On (b)(6) 2022, the tria ureteral stent was successfully placed in the left ureter under fluoroscopy.No issues were reported with the device during placement.The procedure was performed without any complications.Discharge medications included acetaminophen (tylenol), alpha blocker, antibiotic, and nsaids.On (b)(6) 2022, the patient experienced mild dysuria and mild gross hematuria possibly related to the device and stent removal procedure.Bactrim medication was given to the patient.The adverse event was reported to be resolved on (b)(6) 2022.There were no new device implanted.Stent removal procedure information is unknown.
Additional Manufacturer Narrative
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.
Event or Problem Description
Bsc aware date (b)(6) 2022 it was reported to boston scientific corporation that a tria ureteral stent was used in a stent placement study procedure indicated for stone management; laser lithotripsy in left ureter performed on (b)(6) 2022 as part of the (b)(4) double-j registry clinical study.On (b)(6) 2022, the tria ureteral stent was successfully placed in the left ureter under fluoroscopy.No issues were reported with the device during placement.The procedure was performed without any complications.Discharge medications included acetaminophen (tylenol), alpha blocker, antibiotic, and nsaids.On (b)(6) 2022, the patient experienced mild dysuria and mild gross hematuria possibly related to the device and stent removal procedure.Bactrim medication was given to the patient.The adverse event was reported to be resolved on (b)(6) 2022.There were no new device implanted.Stent removal procedure information is unknown.Additional information received on (b)(6) 2022 stating that on (b)(6) 2022, the stent was removed successfully at home as per the initial plan.Pain control was required and oral pain medication was given to the patient.The stent was not difficult to remove and was removed at this attempt.Ureteral stent removal performed as indicated per dfu.
Additional Manufacturer Narrative
Block g3: study: (b)(4) double-j registry clinical study.Block h6: patient code e1302 captures the reportable event of hematuria.Patient code e1301 captures the reportable event of dysuria.Impact code f2303 captures the reportable event of medication required.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.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 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: 15089793
• Report Number: 3005099803-2022-03891
• Device Sequence Number: 5161662
• Product Code: FAD
• UDI-Device Identifier: 08714729959922
• UDI-Public: 08714729959922
• 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: 2022
• Device Explanted Year: 2022
• 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): 08/19/2022

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: 10/17/2023
• Device Model Number: M0061903310
• Device Catalogue Number: 1983-02
• Device Lot Number: 0026203496
• 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
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2020
• 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: 59 YR
• Patient Sex: Female