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

Model Number	M0061902220
Medical Device Problem Codes	Calcified (1077); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a tria ureteral stent was used in a stent placement procedure for malignant obstruction in the left ureter performed on (b)(6) 2022, as part of the u0652 double-j registry clinical study.The subject was pre-stented on (b)(6) 2021 which was removed on (b)(6) 2022, and a new tria ureteral stent was placed retrograde on the left ureter under cystoscopy.The stent was successfully implanted under the direction for use and was performed without any complications.Discharge medications included antibiotic and phenazopyridine.On (b)(6) 2022, the stent was removed successfully as per the initial plan.Pain control was required and monitored anesthesia care (mac).The stent was difficult to remove due to encrustation of stent but was successfully removed with the use of cysto/graspers.The stent was still able to drain at the time of the procedure.According to the complainant, it was found that the tria ureteral stent was encrusted.A new stent was implanted to the patient.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a tria ureteral stent was used in a stent placement procedure for malignant obstruction in the left ureter performed on (b)(6) 2022, as part of the u0652 double-j registry clinical study.The subject was pre-stented on (b)(6) 2021 which was removed on (b)(6) 2022, and a new tria ureteral stent was placed retrograde on the left ureter under cystoscopy.The stent was successfully implanted under the direction for use and was performed without any complications.Discharge medications included antibiotic and phenazopyridine.On (b)(6) 2022, the stent was removed successfully as per the initial plan.Pain control was required and monitored anesthesia care (mac).The stent was difficult to remove due to encrustation of stent but was successfully removed with the use of cysto/graspers.The stent was still able to drain at the time of the procedure.According to the complainant, it was found that the tria ureteral stent was encrusted.A new stent was implanted to the patient.There were no patient complications reported as a result of this event.Additional information was received on december 05, 2022, the onset date of the event difficulty removing stent and encrustation was on (b)(6) 2022, with the onset latency of 98 days.
Additional Manufacturer Narrative
H6: medical device problem code a040501 captures the reportable event of stent calcified.Medical device problem code a150207 captures the reportable event of stent difficult to remove.H11: block b5 has been updated based on the additional information received on december 05, 2022.

• 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: 15807241
• Report Number: 3005099803-2022-06650
• Device Sequence Number: 5616487
• Product Code: FAD
• UDI-Device Identifier: 08714729937845
• UDI-Public: 08714729937845
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K190603
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2024
• Device Model Number: M0061902220
• Device Catalogue Number: 1983-01
• Device Lot Number: 0027700080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 12/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• 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
• Patient Age: 76 YR
• Patient Sex: Male