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

Model Number	M0061921230
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of coil detachment of device or device material.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was used in a transurethral thulium laser lithotripsy of ureter procedure.During the procedure and inside the patient, when the stent was positioned and adjusted, it was noticed that the stent was fractured.The procedure was completed with another different model and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a0401 captures the reportable event of coil detachment of stent shaft break.Device code a0406 captures the reportable event of stent material deformation.Updated block a1: patient identifier, and block h6: device code, based on the additional information received on april 06, 2025.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was used in a transurethral thulium laser lithotripsy of ureter procedure.During the procedure and inside the patient, when the stent was positioned and adjusted, it was noticed that the stent was fractured.The procedure was completed with another different model and there were no patient complications reported.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was used in a transurethral thulium laser lithotripsy of ureter procedure.During the procedure and inside the patient, when the stent was positioned and adjusted, it was noticed that the stent was fractured.The procedure was completed with another different model and there were no patient complications reported.
Additional Manufacturer Narrative
H6: device code a0401 captures the reportable event of stent shaft break.Device code a0406 captures the reportable event of stent material deformation.H11: investigation analysis: upon receipt at our quality assurance laboratory, this polaris ultra stent underwent a thorough analysis.Visual analysis identified that the stent shaft was detached into two parts, and one drainage hole was deformed.The reported event of stent shaft break was confirmed.The detached part and the suture was not returned for analysis.Based on the information available and analysis results, it is possible to conclude that the issue of one drainage hole deformed, could be caused by operational factors.Probably a manipulation during the procedure caused the detachment of the stent shaft, which have caused the deformation of one of the drainage holes.The retrieval line may be removed before placement at the physician's discretion.If the retrieval line gets entangled in the stent coil and is removed using excess force, the stent can get "detached/separated" during the preparation affecting the performance of the device.A conclusion code of adverse event related to procedure was assigned to this investigation.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.

• Brand Name: POLARIS? ULTRA
• 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: 21828015
• Report Number: 2124215-2025-22917
• Device Sequence Number: 4198127
• Product Code: FAD
• UDI-Device Identifier: 08714729124320
• UDI-Public: (01)08714729124320(17)270701(10)34349212
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K010002
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2025

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: M0061921230
• Device Catalogue Number: M0061921230
• Device Lot Number: 0034349212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: 04/06/2025; 05/26/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 05/06/2025; 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 84 KG