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

Model Number M0061552310

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

Patient Problem Urinary Tract Infection (2120)

Event Date 05/29/2022

Event Type  Injury  

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 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
• 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: 16714282
• MDR Text Key: 313152539
• Report Number: 3005099803-2023-01751
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729421078
• UDI-Public: 08714729421078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030503
• 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
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• 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; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female