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 Micturition Urgency (1871); Pain (1994); Dysuria (2684)

Event Date 07/01/2022

Event Type  Injury  

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 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.

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 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.

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 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
• 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: 15183975
• MDR Text Key: 297439788
• Report Number: 3005099803-2022-04267
• 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,Followup
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2021
• 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: 33 YR
• Patient Sex: Female