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 Problem Abdominal Pain (1685)

Event Date 03/13/2020

Event Type  Injury  

Manufacturer Narrative

Report source: clinical study: (b)(6).(b)(4).The complainant indicated that the device is not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Note: this report is one of two complaints that pertain to the same event ((mfr.Report #3005099803-2020-01696).It was reported to boston scientific corporation that the tria ureteral stents were used in a stent placement procedure for stone management in the right and left ureters performed on (b)(6) 2020 as a part of the (b)(6) clinical study.On (b)(6) 2020, the stents were successfully implanted in the right and left ureters, and the patient was prescribed alpha blocker and nsaids at discharge.No issues were reported with the device during placement.According to the complainant, during the planned stent removal procedure, on (b)(6) 2020, the stent was successfully removed from the patient via retrieval line without any difficulty.Reportedly, the patient experienced abdominal pain and was given morphine, toradol, and hydrocodone.There were no new device implanted.No issues were noted with the devices during removal.On (b)(6) 2020, the event was considered resolved.

Event Description

Note: this report is one of two complaints that pertain to the same event ((mfr report #3005099803-2020-01695 and mfr.Report #3005099803-2020-01696).It was reported to boston scientific corporation that the tria ureteral stents were used in a stent placement procedure for stone management in the right and left ureters performed on (b)(6) 2020 as a part of the double-j registry clinical study.On (b)(6) 2020, the stents were successfully implanted in the right and left ureters, and the patient was prescribed alpha blocker and nsaids at discharge.No issues were reported with the device during placement.According to the complainant, during the planned stent removal procedure, on (b)(6) 2020, the stent was successfully removed from the patient via retrieval line without any difficulty.Reportedly, the patient experienced abdominal pain and was given morphine, toradol, and hydrocodone.There were no new device implanted.No issues were noted with the devices during removal.On (b)(6) 2020, the event was considered resolved.Additional information received that the relationship to study device is not related.

Manufacturer Narrative

Block g3: clinical study: double-j registry.Block h6: patient code e1002 captures the reportable event of abdominal pain.Block h10: the complainant indicated that the device is not available for return; 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.

• 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: 9969845
• MDR Text Key: 189617610
• Report Number: 3005099803-2020-01695
• 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
• Report Date: 03/24/2022

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: 03/02/2022
• Supplement Dates FDA Received: 03/24/2022
• 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: 30 YR
• Patient Sex: Female
• Patient Weight: 68 KG