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

Model Number	M0061903220
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: device problem a0501 captures the reportable event of coil detached.
Event or Problem Description
It was reported that on (b)(6) 2024, the patient had a successful tria ureteral stent placement.On (b)(6) 2024, the patient returned for ureteroscopic stone extraction with laser lithotripsy; removal and reinsertion of ureteral stent.A follow up was suggested concerning the foreign body found that probably a broken piece of the stent and presence of residual stones, and was recommended to undergo second ureteroscopy with laser lithotripsy and removal of foreign body.On (b)(6) 2024, a cystoscopy procedure was performed for stent removal and foreign body removal of the broken stent tip from the implanted stent on (b)(6) 2024.No stent reinsertion required.It was reported that there were no patient complications reported after each procedure.The condition of the patient at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: device problem a0501 captures the reportable event of coil detached.Patient code e2008 captures the reportable event of an unretrieved device fragment.Block h11: correction to block h6 (patient code).
Event or Problem Description
It was reported that on (b)(6) 2024, the patient had a successful ureteral stent placement.On (b)(6) 2024, the patient returned for ureteroscopic stone extraction with laser lithotripsy, removal and reinsertion of ureteral stent.A follow up was suggested concerning the foreign body found that probably a broken piece of the stent and presence of residual stones and was recommended to undergo second ureteroscopy with laser lithotripsy and removal of foreign body if indeed 1 was present.On (b)(6) 2024, a cystoscopy procedure was performed for stent removal, foreign body removal of the broken stent tip that was previously implanted on (b)(6) 2024.No stent reinsertion required.It was reported that there were no patient complications reported after each procedure.The report is one of two complaints that pertain to the same event (mfr.Report # 2124215-2024-36840 and mfr.Report # 2124215-2024-46280).

• 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: 19842630
• Report Number: 2124215-2024-46280
• Device Sequence Number: 20752116
• Product Code: FAD
• UDI-Device Identifier: 08714729959892
• UDI-Public: 08714729959892
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K191609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0061903220
• Device Catalogue Number: 1983-02
• Device Lot Number: 0033085569
• 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: 07/03/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 08/27/2024
• Date Device Manufactured: 12/19/2023
• 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: Other
• Patient Age: 81 YR
• Patient Sex: Unknown
• Patient Weight: 97 KG