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

Model Number	M0061552320
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf code a0406 captures the reportable event of stent deformed.
Event or Problem Description
It was reported that, during the ureteroscopy lithotripsy procedure resistance was encountered upon insertion of a polaris loop ureteral stent.The device became blocked upon reaching the ureter and could not be advanced further.The stent was removed and found to be deformed.The procedure was completed successfully with the same polaris loop ureteral stent.No patient complications were reported as a result of this event.
Event or Problem Description
It was reported that, during the ureteroscopy lithotripsy procedure resistance was encountered upon insertion of a polaris loop ureteral stent.The device became blocked upon reaching the ureter and could not be advanced further.The stent was removed and found to be deformed.The procedure was completed successfully with the same polaris loop ureteral stent.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf code a0406 captures the reportable event of stent deformed.Block h11: the returned polaris loop ureteral stent was analyzed, and during the inspection, it was found that the stent shaft buckled, which confirm the reported event.The analysis performed to the returned device; it is possible to conclude that this problem could be caused by operational factors.If the positioner is advanced with excess force over the guidewire the stent can get buckled/accordioned resulting in a difficulty or unable to advance the stent to the target site.Based on the analysis results regarding the observed stent deformed, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.

• 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: 23701077
• Report Number: 2124215-2025-88238
• Device Sequence Number: 10629125
• Product Code: FAD
• UDI-Device Identifier: 08714729421085
• UDI-Public: (01)08714729421085(17)280318(10)36079186
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 01/08/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 12/13/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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