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

Model Number M0061903330

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

Patient Problem Pain (1994)

Event Date 12/02/2021

Event Type  Injury  

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 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.

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 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
• 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: 13169925
• MDR Text Key: 285038966
• Report Number: 3005099803-2022-00002
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729959946
• UDI-Public: 08714729959946
• 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: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 72 KG