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

Model Number M0061903310

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

Patient Problem Pain (1994)

Event Date 04/22/2022

Event Type  Injury  

Event 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.

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
• 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: 14607463
• MDR Text Key: 293446630
• Report Number: 3005099803-2022-02993
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729959922
• UDI-Public: 08714729959922
• 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
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 94 KG