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 Code	Pain (1994)
Date of Event	04/22/2022
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 for stone management for stones in the right ureter performed on (b)(6) 2022 as part of the u0652 double-j registry clinical study.The subject was pre-stented on (b)(6) 2022 with one stent to the right ureter, which was removed on (b)(6) 2022 in operating room.On (b)(6) 2022, the tria ureteral stent was successfully placed for stone management laser lithotripsy (with or without extraction) in the right ureter.No issues were reported with the device during placement.Discharge medications included alpha blocker, anticholinergic, nsaids, and phenazopyridine.According to the complainant, following the procedure, on (b)(6) 2022, the patient had experienced moderate right flank pain.The patient was given tylenol es, advil dual and oxybutynin to treat the pain.A planned stent removal procedure was performed and the stent was successfully removed without any difficulty.Oral pain control was given to the patient.There were no new device implanted.No issues were noted with the devices during removal.On (b)(6) 2022, the event was considered resolved.
Additional Manufacturer Narrative
Study source: (b)(6).(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: 14607463
• Report Number: 3005099803-2022-02993
• Device Sequence Number: 12103986
• 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
• Report Date (Section B): 06/06/2022

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: 10/17/2023
• 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: 05/12/2022
• Initial Report FDA Received Date: 06/06/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 94 KG