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	Micturition Urgency (1871); Pain (1994); Dysuria (2684)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Study: u0652 double-j registry clinical study.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; 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.
Event or Problem Description
It was to reported to boston scientific corporation that a previously implanted percuflex plus ureteral stent was removed from the left ureter, performed on (b)(6) 2022 as part of the u0652 double-j registry clinical study.On (b)(6) 2022, the percuflex plus ureteral stent was successfully placed for stone management in the left ureter, and the patient was prescribed the discharge medications alpha blocker, anticholinergic, and phenazopyridine.No issues were noted with the device.On (b)(6) 2022, the patient had experienced a left and right flank pain.The patient was given oxybutynin, pyridium to treat the pain.During the planned stent removal performed on (b)(6) 2022, the percuflex plus ureteral stent was successfully removed from the patient without any difficulty.There were no new device implanted.On (b)(6) 2022 the event was considered resolved.
Additional Manufacturer Narrative
Block g3: study: u0652 double-j registry clinical study.Block h6: medical problem code e2330 is being used to capture the reportable issue of pain.Medical problem code e1301 is being used to capture the reportable issue of dysuria.Medical problem code e1304 is being used to capture the reportable issue of urinary urgency.Patient impact code f2303 captures the reportable event of medication required.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; 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.Block h11; updated block b5 (describe event or problem) correction to block a1 (patient identifier), block a2 (sex), block b1 (adverse event/product problem) and block b3 (date of event).
Event or Problem Description
It was to reported to boston scientific corporation that a previously implanted tria ureteral stent was removed from the left ureter, performed on (b)(6) 2022 as part of the u0652 double-j registry clinical study.The patient was pre-stented on (b)(6) 2022 with a stent to the left ureter, which was removed on (b)(6) 2022.On (b)(6) 2022,, the tria ureteral stent was successfully placed retrograde on the left side under fluoroscopy for stone management in the left ureter, and the patient was prescribed the discharge medications; alpha blocker, anticholinergic, and phenazopyridine.No issues were noted with the device.The patient's condition following stent placement, was reported to be experiencing mild dysuria, increased urinary urgency and increased pain (moderate).The patient was given oxybutynin, pyridium, and oxycodone.On (b)(6) 2022, the mild dysuria and urinary urgency were considered resolved.On july 28, 2022, the pain was considered resolved.On (b)(6) 2022, the the stent was removed successfully without any difficulty, and there were no new device implanted.
Additional Manufacturer Narrative
Block g3: study: u0652 double-j registry clinical study.Block h6: medical problem code e2330 is being used to capture the reportable issue of pain.Medical problem code e1301 is being used to capture the reportable issue of dysuria.Medical problem code e1304 is being used to capture the reportable issue of urinary urgency.Patient impact code f2303 captures the reportable event of medication required.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; 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.Block h11: updated block h6 (medical problem code e1301: dysuria) (medical problem code e1304: urinary urgency).
Event or Problem Description
It was to reported to boston scientific corporation that a previously implanted percuflex plus ureteral stent was removed from the left ureter, performed on (b)(6) 2022 as part of the u0652 double-j registry clinical study.On (b)(6) 2022, the percuflex plus ureteral stent was successfully placed for stone management in the left ureter, and the patient was prescribed the discharge medications alpha blocker, anticholinergic, and phenazopyridine.No issues were noted with the device.On (b)(6) 2022, the patient had experienced a left and right flank pain.The patient was given oxybutynin, pyridium to treat the pain.During the planned stent removal performed on (b)(6) 2022, the percuflex plus ureteral stent was successfully removed from the patient without any difficulty.There were no new device implanted.On (b)(6) 2022 the event was considered resolved.

• 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: 15183975
• Report Number: 3005099803-2022-04267
• Device Sequence Number: 6541153
• Product Code: FAD
• UDI-Device Identifier: 08714729959939
• UDI-Public: 08714729959939
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K191609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 08/25/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/23/2024
• Device Model Number: M0061903320
• Device Catalogue Number: 1983-02
• Device Lot Number: 0028447440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 07/21/2022; 08/23/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 08/16/2022; 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2021
• 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: 33 YR
• Patient Sex: Female