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

Model Number	M0061903320
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Pain (1994)
Date of Event	11/23/2021
Type of Reportable Event	Serious Injury
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 right ureter under cystoscopy, performed on (b)(6) 2021 as part of the (b)(6) clinical study.The stent placement procedure for stone management was performed including laser lithotripsy (with or without extraction).The subject was pre-stented on (b)(6) 2021 to the left ureter which was removed on (b)(6) 2021 in the operating room.On (b)(6) 2021, the right side stent was successfully implanted to the patient.The patient was prescribed with acetaminophen, antibiotic, phenazopyridine, narcotic analgesics and nsaids at discharge.No issues were noted with the devices.According to the complainant, on (b)(6) 2021, the right side stent was removed successfully as per initial plan.Stent was not difficult to remove and oral pain medication was not required.On (b)(6) post procedure, sever pain was experienced by the patient and was given oxycodone/acetaminophen.The event was considered to be resolved as of on (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 Manufacturer Narrative
Clinical study: (b)(6).(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 right ureter under cystoscopy, performed on (b)(6) 2021 as part of the (b)(6) double-j registry clinical study.The stent placement procedure for stone management was performed including laser lithotripsy (with or without extraction).The subject was pre-stented on (b)(6) 2021 to the left ureter which was removed on (b)(6) 2021 in the operating room.On (b)(6) 2021, the right side stent was successfully implanted to the patient.The patient was prescribed with acetaminophen, antibiotic, phenazopyridine, narcotic analgesics and nsaids at discharge.No issues were noted with the devices.According to the complainant, on (b)(6) 2021, the right side stent was removed successfully as per initial plan.Stent was not difficult to remove and oral pain medication was not required.On (b)(6) 2021 post procedure, severe pain was experienced by the patient and was given oxycodone/acetaminophen.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 the stent was removed in an office procedure room via cysto/graspers.There was pain after stent explant.Fever is no longer part of the event.A new stent was not implanted.
Additional Manufacturer Narrative
Block g3: clinical study: (b)(6) double-j registry.Block h6: patient code e2330 captures the reportable event of pain.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.Block h11: additional information: a1: patient identifier.A4: weight.Updated b5.E1: initial reporter phone; initial reporter email.Correction to d5: operator of device; e2: health professional; e3: occupation.

• 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: 13101427
• Report Number: 3005099803-2021-08010
• Device Sequence Number: 14599831
• Product Code: FAD
• UDI-Device Identifier: 08714729959939
• UDI-Public: 08714729959939
• 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
• 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): 01/28/2022

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: 04/22/2024
• Device Model Number: M0061903320
• Device Catalogue Number: 1983-02
• Device Lot Number: 0027196214
• 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: 12/03/2021
• Supplement Date Received by Manufacturer: 01/03/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 52 KG