MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION POLARIS LOOP; STENT, URETERAL

Model Number	M0061552310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	05/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Study: u0652 double-j registry clinical study.Adverse event problem: imdrf patient code e1310 captures the reportable event of urinary tract infection.
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop ureteral stent was implanted during a stent placement for stone management, laser lithotripsy procedure in the right ureter on (b)(6) 2022, as part of the u0652 double-j registry clinical study.On (b)(6) 2022, the stent was successfully implanted, and a medication of alpha blocker, antibiotic, and narcotic analgesics (opioids) was given for the patient.On (b)(6) 2022, it was noted that the patient experienced urinary tract infection and was hospitalized for nine days.On (b)(6) 2022, the event was considered resolved.There was no new stent implanted.

• Brand Name: POLARIS LOOP
• 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: 16714282
• Report Number: 3005099803-2023-01751
• Device Sequence Number: 16592212
• Product Code: FAD
• UDI-Device Identifier: 08714729421078
• UDI-Public: 08714729421078
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K030503
• 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
• Report Date (Section B): 04/11/2023

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: 10/28/2024
• Device Model Number: M0061552310
• Device Catalogue Number: 155-231
• Device Lot Number: 0028294381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• 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; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female