MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Polaris? Loop; stent, ureteral

Model Number	M0061552320
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a polaris loop ureteral stent was used in a retrograde intrarenal surgery (rirs) procedure.During the procedure and inside the patient, it was noticed that the stent was broken.The procedure was completed with another of the same device and there were no patient complications reported.The patient's condition following the procedure was stable.A photo of the complaint device was provided and showed that the stent loops were broken.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent torn material inside the patient.

• 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: 50756334
• Report Number: 2124215-2026-48935
• Device Sequence Number: 9395914
• Product Code: FAD
• UDI-Device Identifier: 08714729421085
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K030503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: 0036079186
• 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: 08/18/2026
• Initial Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 03/19/2025
• 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 Sex: Unknown