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

Model Number	M0061902220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report source: study: (b)(6).(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was to reported boston scientific corporation that a previously implanted tria firm ureteral stent was removed from the left ureter, performed on (b)(6) 2022 as part of the (b)(6) clinical study.The tria ureteral stent was implanted on (b)(6) 2021 with no problems reported during placement.On (b)(6) 2022, it was reported that the patient presented in the er with infection.On (b)(6) 2022, the tria ureteral stents was successfully removed from the patient in the operating room.No issues were reported with the device during removal.A tria firm ureteral stent was successfully placed retrograde on the left side under fluoroscopy.On (b)(6) 2022 the event was considered resolved.
Event or Problem Description
It was to reported boston scientific corporation that a previously implanted tria firm ureteral stent was removed from the left ureter, performed on (b)(6) 2022 as part of the u0652 double-j registry clinical study.The tria ureteral stent was implanted on (b)(6) 2021 with no problems reported during placement.On (b)(6) 2022, it was reported that the patient presented in the er with infection.On (b)(6) 2022, the tria ureteral stents was successfully removed from the patient in the operating room.No issues were reported with the device during removal.A tria firm ureteral stent was successfully placed retrograde on the left side under fluoroscopy.On (b)(6) 2022 the event was considered resolved.Additional information received that there was also an infection in the left kidney.
Additional Manufacturer Narrative
Block g3: study: u0652 double-j registry clinical study.Block h6: medical problem code e1906 is being used to capture the reportable issue of patient infection.Health impact code f23 captures the reportable unexpected medical intervention.Health impact code f2303 captures the reportable medication required health impact code f08 captures the reportable hospitalization.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h11: block b5 have been updated based on additional information received september 09, 2022.
Event or Problem Description
It was to reported boston scientific corporation that a previously implanted tria firm ureteral stent was removed from the left ureter, performed on (b)(6) 2022, as part of the (b)(6) double-j registry clinical study.The tria ureteral stent was implanted on (b)(6) 2021, with no problems reported during placement.On november 21, 2022, it was reported that the patient presented in the er with infection.On november 22, 2022, the tria ureteral stents was successfully removed from the patient in the operating room.No issues were reported with the device during removal.A tria firm ureteral stent was successfully placed retrograde on the left side under fluoroscopy.On november 24, 2022, the event was considered resolved.Additional information received that there was also an infection in the left kidney.Additional information received on january 19, 2023, that the left kidney infection is no longer reportable as it is not related to the study device, index procedure or stent removal procedure.
Additional Manufacturer Narrative
Block b3: study: u0652 double-j registry clinical study.Block h10: additional information: block b5 and h6 have been updated based on additional information received january 19, 2023.Correction: block h6 has been updated to code for e2403 no clinical signs, symptoms or conditions and impact code f26 no health consequences or impact deeming this a non-reportable scenario, due to the additional information received on january 19, 2023, stating the left kidney infection is no longer reportable as it is not related to the study device, index procedure or stent removal procedure.

• Brand Name: TRIA FIRM
• 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: 13830560
• Report Number: 3005099803-2022-01187
• Device Sequence Number: 1401834
• Product Code: FAD
• UDI-Device Identifier: 08714729937845
• UDI-Public: 08714729937845
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K190603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2023

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: 02/10/2023
• Device Model Number: M0061902220
• Device Catalogue Number: 1983-01
• Device Lot Number: 0025191372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 09/09/2022; 01/19/2023
• Initial Report FDA Received Date: 03/20/2022
• Supplement Report FDA Received Date: 09/22/2022; 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2020
• 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: 49 YR
• Patient Sex: Male