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 Abdominal Pain (1685); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/17/2020

Event Type  Injury  

Manufacturer Narrative

Report source: clinical study: (b)(6).(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a tria ureteral stent was used in a stent placement procedure for stone management for stones in the right kidney performed on (b)(6) 2020 as part of the (b)(6) clinical study.On (b)(6) 2020, the tria ureteral stent was placed in the right ureter for stone management for stones in the right ureter.No issues were reported with the device during placement.According to the complainant, following the procedure on (b)(6) 2020, the patient had experienced a right flank pain around the abdomen.The patient was given fetanyl and morphine to treat the pain.The patient outcome is considered recovering / resolving.On (b)(6) 2020, during the planned stent removal procedure, the stent was successfully removed via the retrieval line with no difficulty.Oral pain control was given during this procedure.There were no new device implanted.No issues were noted with the devices during removal.

Event Description

It was reported to boston scientific corporation that a tria ureteral stent was used in a stent placement procedure for stone management for stones in the right kidney performed on (b)(6) 2020 as part of the u0652 double-j registry clinical study.On (b)(6) 2020, the tria ureteral stent was placed in the right ureter for stone management for stones in the right ureter.No issues were reported with the device during placement.According to the complainant, following the procedure on (b)(6), 2020, the patient had experienced a right flank pain around the abdomen.The patient was given fetanyl and morphine to treat the pain.The patient outcome is considered recovering / resolving.On (b)(6), 2020, during the planned stent removal procedure, the stent was successfully removed via the retrieval line with no difficulty.Oral pain control was given during this procedure.There were no new device implanted.No issues were noted with the devices during removal.** additional information received on (b)(6), 2020** the patient outcome is considered resolved on (b)(6), 2020.

Manufacturer Narrative

Block g3: clinical study: u0652 double-j registr.Block h6: patient code 1685 captures the reportable event of abdominal pain.Conclusion code 4316 is being used in lieu of an adequate conclusion code for "device not returned".Block h10: the complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.If any further relevant information is received, a supplemental mdr will be filed.Additional information: block b5 (event description).

Manufacturer Narrative

Block g3: clinical study: (b)(6).Block h6: conclusion code d17 is being used in lieu of an adequate conclusion code for "device not returned".Block h10: the complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.If any further relevant information is received, a supplemental mdr will be filed.Additional information: block b5 (event description).Additional information: block a1: patient identifier.Block b5 (event description).Removed h6 patient code e1002 abdominal pain.

Event Description

It was reported to boston scientific corporation that a tria ureteral stent was used in a stent placement procedure for stone management for stones in the right kidney performed on (b)(6), 2020 as part of the u0652 double-j registry clinical study.On (b)(6), 2020, the tria ureteral stent was placed in the right ureter for stone management for stones in the right ureter.No issues were reported with the device during placement.According to the complainant, following the procedure on (b)(6), 2020, the patient had experienced a right flank pain around the abdomen.The patient was given fetanyl and morphine to treat the pain.The patient outcome is considered recovering / resolving.On (b)(6), 2020, during the planned stent removal procedure, the stent was successfully removed via the retrieval line with no difficulty.Oral pain control was given during this procedure.There were no new device implanted.No issues were noted with the devices during removal.** additional information received on june 25, 2020** the patient outcome is considered resolved on (b)(6), 2020.** additional information received on june 22, 2021** the relationship to index procedure and relationship to study stent removal procedure has been updated from "unlikely" by the site to "not related" for subject (b)(6) with adverse event term right flank pain that wraps around abdomen.

Event Description

It was reported to boston scientific corporation that a tria ureteral stent was used in a stent placement procedure for stone management for stones in the right kidney performed on (b)(6) 2020 as part of the u0652 double-j registry clinical study.On (b)(6) 2020, the tria ureteral stent was placed in the right ureter for stone management for stones in the right ureter.No issues were reported with the device during placement.According to the complainant, following the procedure on (b)(6) 2020, the patient had experienced a right flank pain around the abdomen.The patient was given fetanyl and morphine to treat the pain.The patient outcome is considered recovering / resolving.On march 24, 2020, during the planned stent removal procedure, the stent was successfully removed via the retrieval line with no difficulty.Oral pain control was given during this procedure.There were no new device implanted.No issues were noted with the devices during removal.** additional information received on june 25, 2020** the patient outcome is considered resolved on march 30, 2020.** additional information received on june 22, 2021** the relationship to index procedure and relationship to study stent removal procedure has been updated from "unlikely" by the site to "not related" for subject (b)(6) with adverse event term right flank pain that wraps around abdomen.** additional information received on may 25, 2022** additional medication of percocet was given to the patient.

Manufacturer Narrative

Block g3: clinical study: (b)(6).Block h6: conclusion code d17 is being used in lieu of an adequate conclusion code for "device not returned".Block h10: the complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.If any further relevant information is received, a supplemental mdr will be filed.Additional information: block b5 (event description).

• 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: 9970011
• MDR Text Key: 189617931
• Report Number: 3005099803-2020-01714
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729959892
• UDI-Public: 08714729959892
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/16/2022

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 Expiration Date: 10/06/2022
• Device Model Number: M0061903220
• Device Catalogue Number: 1983-02
• Device Lot Number: 0024550782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2020
• Initial Date FDA Received: 04/16/2020
• Supplement Dates Manufacturer Received: 06/25/2020; 06/22/2021; 05/25/2022
• Supplement Dates FDA Received: 07/20/2020; 07/16/2021; 06/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2019
• 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
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 79 KG