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

Model Number M0061903220

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

Patient Problems Unspecified Infection (1930); Sepsis (2067); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 02/21/2022

Event Type  Injury  

Manufacturer Narrative

(b)(6).Study: u0652 double-j registry clinical study.(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 Description

It was reported to boston scientific corporation that a tria soft ureteral stent was implanted during a laser lithotripsy procedure in the right ureter on (b)(6) 2022 as part of the u0652 double-j registry clinical study.On (b)(6) 2022 the stent was successfully implanted and the patient was prescribed alpha blocker and nsaids at discharge.It was reported the stent was removed successfully on (b)(6) 2019 and pain control was not required.On (b)(6) 2022 following stent removal, it was reported that the patient was brought to the emergency room and had ureteral interventional procedure stent insertion (reimplantation) on the right side and was given a medication of piperacillin and tazobactam.On (b)(6) 2022 the event was considered resolved.

Manufacturer Narrative

Block e1: initial reporter state: (b)(6).Block g3: study: u0652 double-j registry clinical study.Block h6: patient impact code f2303 captures the reportable event of medication required.Patient impact code f08 captures the reportable event of hospitalization.Block h11: block b5 have been updated based on additional information received on august 30, 2022.

Event Description

It was reported to boston scientific corporation that a tria soft ureteral stent was implanted during a laser lithotripsy procedure in the right ureter on (b)(6) 2022 as part of the u0652 double-j registry clinical study.On (b)(6) 2022 the stent was successfully implanted and the patient was prescribed alpha blocker and nsaids at discharge.It was reported the stent was removed successfully on (b)(6) 2022 and pain control was not required.On february 21, 2022, following stent removal, it was reported that the patient was brought to the emergency room and had ureteral interventional procedure stent insertion (reimplantation) on the right side and was reported to have a septic stone and was given a medication of piperacillin and tazobactam.On february 23, 2022 the event was considered resolved.

Manufacturer Narrative

E1: initial reporter state: bc v5z 1m9 g3: study: u0652 double-j registry clinical study.H6: patient impact code f2303 captures the reportable event of medication required.Patient impact code f08 captures the reportable event of hospitalization.Patient code e0306 captures the reportable event of sepsis.Patient code e1906 captures the reportable event of unspecified infection.H11: block b5 have been updated based on additional information received on august 30, 2022.Block b5 have been updated based on additional information received on september 23, 2022.Updated block h6 for patient code.

Event Description

It was reported to boston scientific corporation that a tria soft ureteral stent was implanted during a laser lithotripsy procedure in the right ureter on (b)(6) 2022 as part of the u0652 double-j registry clinical study.On (b)(6) 2022 the stent was successfully implanted and the patient was prescribed alpha blocker and nsaids at discharge.It was reported the stent was removed successfully on (b)(6) 2022 and pain control was not required.On (b)(6) 2022, following stent removal, it was reported that the patient was brought to the emergency room and had ureteral interventional procedure stent insertion (reimplantation) on the right side and was reported to have a septic stone and was given a medication of piperacillin and tazobactam.On (b)(6) 2022 the event was considered resolved.Additional information received on september 19, 2022 reported that the patient experienced a septic kidney stone, sepsis or infection, requiring antibiotics.

Event Description

It was reported to boston scientific corporation that a tria soft ureteral stent was implanted during a laser lithotripsy procedure in the right ureter on february 14, 2022 as part of the u0652 double-j registry clinical study.On (b)(6) 2022 the stent was successfully implanted and the patient was prescribed alpha blocker and nsaids at discharge.It was reported the stent was removed successfully on (b)(6) 2022 and pain control was not required.On (b)(6) 2022, following stent removal, it was reported that the patient was brought to the emergency room and had ureteral interventional procedure stent insertion (reimplantation) on the right side and was reported to have a septic stone and was given a medication of piperacillin and tazobactam.On (b)(6) 2022 the event was considered resolved.Additional information received on september 19, 2022 reported that the patient experienced a septic kidney stone, sepsis or infection, requiring antibiotics.

Manufacturer Narrative

Block e1: initial reporter state: (b)(6).Block g3: study: u0652 double-j registry clinical study.Block h6: patient impact code f2303 captures the reportable event of medication required.Patient impact code f08 captures the reportable event of hospitalization.Patient code e0306 captures the reportable event of sepsis.Patient code e1906 captures the reportable event of unspecified infection.Block h11: block b6 has been corrected.

Manufacturer Narrative

Block g3: study: (b)(4) double-j registry clinical study.Block h6: imdrf impact code f2303 captures the reportable event of medication required.Imdrf impact code f08 captures the reportable event of hospitalization.Imdrf patient code e0306 captures the reportable event of sepsis.Imdrf patient code e1906 captures the reportable event of unspecified infection.Imdrf patient code e2338 captures the reportable event of swelling.Block h11: block b5 have h6 have been updated based on additional information received on february 27, 2023.

Event Description

It was reported that a tria soft ureteral stent was implanted during a laser lithotripsy procedure in the right ureter on (b)(6) 2022, as part of the (b)(4) double-j registry clinical study.On (b)(6) 2022, the stent was successfully implanted, and the patient was prescribed alpha blocker and nsaids at discharge.It was reported the stent was removed successfully on (b)(6) 2022, and pain control was not required.On (b)(6) 2022, following stent removal, it was reported that the patient was brought to the emergency room and had ureteral interventional procedure stent insertion (reimplantation) on the right side and was reported to have a septic stone and was given a medication of piperacillin and tazobactam.The patient was hospitalized (b)(6) 2022.The onset date was on february 21, 2022, with an onset latency of 7 days and with a stop date of february 23, 2022.There was no reported action taken and the event outcome was resolved.Additional information received on september 19, 2022, reported that the patient experienced a septic kidney stone, sepsis or infection, requiring antibiotics.Additional information received on january 19, 2023, reported another device lot number 24951653, that was used in the left ureter.The stent was successfully implanted, and procedure was performed without any complication.Additional information received on february 27, 2023, reported a new event of hydronephrosis with a severity of moderate.The onset date was on (b)(6) 2022, with an onset latency of 7 days and with a stop date of (b)(6) 2022.The clavien-dindo classification was noted as grade iiib.There was no reported action taken and the event was resolved.

Manufacturer Narrative

Block g3: study: u0652 double-j registry clinical study.Block h6: patient impact code f2303 captures the reportable event of medication required.Patient impact code f08 captures the reportable event of hospitalization.Patient code e0306 captures the reportable event of sepsis.Patient code e1906 captures the reportable event of unspecified infection.Block h11: block e1 has been corrected.Block b5 has been corrected.Block b5 has been updated based on additional information received on january 19, 2023.

Event Description

It was reported to boston scientific corporation that a tria soft ureteral stent was implanted during a laser lithotripsy procedure in the right ureter on (b)(6)2022, as part of the u0652 double-j registry clinical study.On (b)(6) 2022, the stent was successfully implanted, and the patient was prescribed alpha blocker and nsaids at discharge.It was reported the stent was removed successfully on (b)(6), 2022, and pain control was not required.On (b)(6)2022, following stent removal, it was reported that the patient was brought to the emergency room and had ureteral interventional procedure stent insertion (reimplantation) on the right side and was reported to have a septic stone and was given a medication of piperacillin and tazobactam.The patient was hospitalized from (b)(6) 2022, to (b)(6) 2022.On (b)(6) 2022, the event was considered resolved.Additional information received on (b)(6)2022, reported that the patient experienced a septic kidney stone, sepsis or infection, requiring antibiotics.Additional information received on (b)(6) 2023, reported another device lot number 24951653, that was used in the left ureter.The stent was successfully implanted, and procedure was performed without any complication.

• 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: 14983085
• MDR Text Key: 295673372
• Report Number: 3005099803-2022-03581
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729959892
• UDI-Public: 08714729959892
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K191609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/20/2023

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
• Device Operator: Health Professional
• Device Model Number: M0061903220
• Device Catalogue Number: 1983-02
• Device Lot Number: 0027999242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/11/2022
• Supplement Dates Manufacturer Received: 08/30/2022; 09/19/2022; 10/24/2022; 01/19/2023; 02/27/2023
• Supplement Dates FDA Received: 09/20/2022; 10/14/2022; 11/16/2022; 02/13/2023; 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female