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

Model Number	M0061921230
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent kinked, inside the patient.
Event or Problem Description
It was reported that during the ureterolithiasis procedure, the blue end had a kink mark.The procedure was completed with another of the same device and the patient condition following procedure was stable.
Additional Manufacturer Narrative
Imdrf device code a0406 captures the reportable event of stent kinked, inside the patient.The polaris ultra ureteral stent was not returned for analysis.During media inspection, it showed a polaris ultra in which the renal coil 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 kink observed.Additionally, bending or kinking during or prior to placement could damage the integrity of the stent.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 ureterolithiasis procedure, the blue end had a kink mark.The procedure was completed with another of the same device and the patient condition following procedure was stable.
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 for analysis.The suture and the positioner did not return for analysis.The reported event of stent kinked will be confirmed.During the media, visual and magnification inspection, that stent was found bent near the renal coil.Additionally, there is evidence of stent calcified that is not related to the reported event.Regarding to the analysis performed to the returned device, it is possible to conclude that this issue could be caused by operational factors.Probably some manipulation during the procedure could have caused kink observed.Regarding the issue of stent calcified found, the event of stent calcified is anticipated in the risk documentation and as potential complications that may be associated with the use of the device, this event is assigned the most probable cause classification of known inherent risk of device which indicates that the adverse event is known.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 ureterolithiasis procedure, the blue end had a kink mark.The procedure was completed with another of the same device and the patient condition following 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: 21246308
• Report Number: 2124215-2025-03161
• Device Sequence Number: 3664172
• Product Code: FAD
• UDI-Device Identifier: 08714729124320
• UDI-Public: (01)08714729124320(17)270301(10)33539606
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2025

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: 0033539606
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: 02/04/2025; 03/12/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 03/05/2025; 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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 Sex: Unknown