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

Model Number	M0061903330
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Health professional was estimated to "yes" based on given information.Report source: clinical study: (b)(6) registry.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a tria ureteral stents was used during a stent placement procedure in the left ureter under cystoscopy, performed on (b)(6) 2021 as part of the (b)(6) clinical study.The stent placement procedure was indicated for stone management ; cystoscopy and left ureteroscopy with ureteral stent placement.On (b)(6) 2021, the left side stent was successfully implanted to the patient.The patient was prescribed with acetaminophen, alpha blocker, antibiotic, narcotic analgesics and nsaids at discharge.No issues were noted with the devices.Post procedure, the patient experienced severe pain that lasted for three weeks.On (b)(6) 2021, the left side stent was removed successfully as per initial plan.Stent was not difficult to remove and oral pain medication was required.The event was considered to be resolved as of (b)(6) 2021.In the physician's assessment, the relationship between the procedure and the event is possibly related, there is no relationship between the adverse event and the bsc guidewire, the stent implant procedure, and the stent removal procedure, a 'casual' relationship between the adverse event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block g3: clinical study: u0652 double-j registry.Block h6: patient code e2330 captures the reportable event of pain.Impact code f2303 captures the reportable event of medical intervention.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a tria ureteral stents was used during a stent placement procedure in the left ureter under cystoscopy, performed on (b)(6) 2021 as part of the u0652 double-j registry clinical study.The stent placement procedure was indicated for stone management ; cystoscopy and left ureteroscopy with ureteral stent placement.On (b)(6) 2021, the left side stent was successfully implanted to the patient.The patient was prescribed with acetaminophen, alpha blocker, antibiotic, narcotic analgesics and nsaids at discharge.No issues were noted with the devices.Post procedure, the patient experienced severe pain that lasted for three weeks.On (b)(6) 2021, the left side stent was removed successfully as per initial plan.Stent was not difficult to remove and oral pain medication was required.The event was considered to be resolved as of (b)(6) 2021.In the physician's assessment, the relationship between the procedure and the event is possibly related, there is no relationship between the adverse event and the bsc guidewire, the stent implant procedure, and the stent removal procedure, a 'casual' relationship between the adverse event.**additional information** it was reported that diclofenac 50mg, tylenol 650mg was given to the patient for pain.The stent was removed by urs laser and there were no new stent implanted.Based upon the medical review assessment, the data reasonably suggest the clinical event pain is anticipated in nature and severity as per the ifu and hazard analysis.Patient was positive for urinary tract infection prior to study stent placement and stent exchange, and was noted to have a positive fungal urinary tract infection on the date the stent was removed/exchanged (prior to the removal of the stent), which is the date her pain started.Therefore it was unknown if the pain was from the infection, or possibly related to the study of the stent, index procedure or study stent removal.On january 14, 2022, it was noted that the fungal urinary tract infection was specified as being not related to the device and not related to the procedure.

• Brand Name: TRIA SOFT
• 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: 13169925
• Report Number: 3005099803-2022-00002
• Device Sequence Number: 11251765
• Product Code: FAD
• UDI-Device Identifier: 08714729959946
• UDI-Public: 08714729959946
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K191609
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2024
• Device Model Number: M0061903330
• Device Catalogue Number: 1983-02
• Device Lot Number: 0027142115
• 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: 12/10/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 72 KG