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

Model Number M0061903320

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

Patient Problems Fever (1858); Pain (1994)

Event Date 11/23/2021

Event Type  Injury  

Event 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.

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 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.

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
• 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: 13101427
• MDR Text Key: 285182808
• Report Number: 3005099803-2021-08010
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729959939
• UDI-Public: 08714729959939
• 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: 01/28/2022

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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 01/03/2022
• Supplement Dates FDA Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2021
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 52 KG