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

Model Number	M0061921320
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the distal end of the double j stent shows an abnormal curvature inside the patient's bladder.The procedure was completed with another of the same device and the patient condition following the procedure was stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent kinked, inside the patient.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable investigation results of stent kinked, inside the patient.Block h11: the polaris ultra ureteral stent was returned with the positioner and pouch for analysis.However, the suture did not return.During media and visual inspection, and device inspection under magnification, it was found that the stent bladder coil and stent shaft was kinked.The reported event of stent kinked will be confirmed.It is possible to conclude that this issue could be caused by operational factors.Probably some manipulation during the procedure could have caused the kink observed on the shaft and bladder coil.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on the event.
Event or Problem Description
It was reported that during the procedure, the distal end of the double j stent shows an abnormal curvature inside the patient's bladder.The procedure was completed with another of the same device and the patient condition following the procedure was stable.
Additional Manufacturer Narrative
H6: imdrf device code a0406 captures the reportable event of stent kinked, inside the patient.H11: the polaris ultra ureteral stent was returned with the positioner and pouch for analysis.However, the suture did not return.During media and visual inspection, and device inspection under magnification, it was found that the stent bladder coil and stent shaft was kinked.The reported event of stent kinked will be confirmed.It is possible to conclude that this issue could be caused by operational factors.Probably some manipulation during the procedure could have caused the kink observed on the shaft and bladder coil.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on the event.Correction to the bsc aware date based on the investigation closure date with the product return analysis.B5, and h6: component codes (2); evaluation method codes; and evaluation result codes has been updated.
Event or Problem Description
It was reported that a polaris ultra ureteral stent during a retrograde intrarenal surgery procedure.During the procedure, it was noticed that the distal end of the stent showed an abnormal curvature inside the patient's bladder.The procedure was completed with another of the same device and the patient condition following the procedure was stable.

• 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: 22503775
• Report Number: 2124215-2025-44893
• Device Sequence Number: 15764650
• Product Code: FAD
• UDI-Device Identifier: 08714729124429
• UDI-Public: (01)08714729124429(17)280128(10)35729385
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2025

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: M0061921320
• Device Catalogue Number: M0061921320
• Device Lot Number: 0035729385
• 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: 06/20/2025
• Supplement Date Received by Manufacturer: 07/28/2025; 08/25/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/22/2025; 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2025
• 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