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

Model Number	M0061903220
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Renal Failure (2041); Fluid Discharge (2686)
Date of Event	07/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2022, was chosen as the best estimate based on the procedure which happened sometime in (b)(6) 2022 and the day of adverse event reported at four days (pod4) post-procedure.Blocks d4, h4: detailed product information was not provided to bsc.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e130501 captures the reportable event of "inadequate kidney drainage." imdrf patient code e2315 captures the reportable event of "drainage from flank incisions." imdrf impact code f1903 captures the reportable event of "stent was removed." imdrf impact code f1901 captures the reportable event of "cystoscopy procedure performed.".
Event or Problem Description
It was reported to boston scientific corporation that a tria soft ureteral stent with side holes device was used to treat a right nephrolithiasis with infundibular stenoses during a right percutaneous nephrostolithotomy (pcnl) of stone greater than 2 cm procedure performed sometime in (b)(6) 2022.Four days post-procedure, the patient presented to the emergency room (er) with drainage from flank incisions.Post-operative computed tomography (ct) revealed distal migration of the ureteral stent, resulting in inadequate kidney drainage.The stent was subsequently removed via cystoscopy.Per physician's assessment, the event was serious, was possibly related to the device, and probably related to the procedure.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21777873
• Report Number: 2124215-2025-19487
• Device Sequence Number: 20980811
• Product Code: FAD
• UDI-Device Identifier: 08714729959892
• UDI-Public: (01)08714729959892
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K191609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/04/2025

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 Model Number: M0061903220
• Device Catalogue Number: M0061903220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 04/04/2025
• 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; Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic