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

Model Number	M0061552320
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Block h6: device code a040601 captures the reportable event of stent buckled material inside the patient.
Event or Problem Description
It was reported that a polaris loop ureteral stent was used in a rigid ureteroscopic lithotripsy procedure in the right renal pelvis.During insertion and inside the patient, it was noticed that the stent was stuck.The procedure was completed with another of the same device and there were no patient complications reported.The patient condition following the procedure was stable.Picture provided by the customer showed that the stent was buckled.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24956094
• Report Number: 2124215-2026-21782
• Device Sequence Number: 9890444
• Product Code: FAD
• UDI-Device Identifier: 08714729421085
• UDI-Public: (01)08714729421085(17)270422(10)33875977
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0061552320
• Device Catalogue Number: M0061552320
• Device Lot Number: 0033875977
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 06/25/2026
• Date Device Manufactured: 04/22/2024
• 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
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 78 KG