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

Model Number	M006192142050
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Material Integrity Problem (2978); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: device code a010402 captures the reportable event of stent migration.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was used in a placement of double j catheter procedure.During insertion, it was noticed that one end of the catheter was damaged.It was also reported that the stent migrated.The procedure was completed with an alternate device and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a010402 captures the reportable event of stent migration.Blocks b3: date of event, and b5, have been updated based on the additional information received on december 23, 2025.Correction to block d4: lot number and expiration date.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was used in a placement of double j catheter procedure.During insertion, it was noticed that one end of the catheter was damaged.It was also reported that the stent migrated.The procedure was completed with an alternate device and there were no patient complications reported.Additional information was received stating that the target anatomy location was in the ureter, the stent could not migrate from the ureter to the kidney, and the procedure was completed with another polaris ultra stent.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was used in a placement of double j catheter procedure in the ureter.During insertion, it was noticed that one end of the catheter was damaged and was difficult to advance when attempted to push from the ureter to the kidney.The procedure was completed with an alternate device and there were no patient complications reported.Investigation of the returned device identified that the stent was buckled.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: device code a040601 captures the reportable investigation result of stent buckled material inside the patient.Block b5 and block h6, have been updated based on the additional information received on january 20, 2026.Block h11: investigation analysis upon receipt at our quality assurance laboratory, this contour ureteral stent underwent a thorough analysis.Visual analysis of the returned device identified that the stent bladder coil was buckled and the tip was torn.The positioner was also returned for analysis.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.Based on the information available and analysis results, it is possible to conclude that this issue could be caused by operational factors.Probably some manipulation during the procedure could have caused buckle and torn on the device.A conclusion code of adverse event related to procedure was assigned to this investigation.
Additional Manufacturer Narrative
Device code a040601 captures the reportable investigation result of stent buckled material inside the patient.Block h11: correction to investigation analysis upon receipt at our quality assurance laboratory, this polaris ultra ureteral stent underwent a thorough analysis.Visual analysis of the returned device identified that the stent bladder coil was buckled and the tip was torn.The positioner was also returned for analysis.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.Based on the information available and analysis results, it is possible to conclude that this issue could be caused by operational factors.Probably some manipulation during the procedure could have caused buckle and torn on the device, and also, could lead to stent/delivery system difficult to advance.A conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was used in a placement of double j catheter procedure in the ureter.During insertion, it was noticed that one end of the catheter was damaged and was difficult to advance when attempted to push from the ureter to the kidney.The procedure was completed with an alternate device and there were no patient complications reported.Investigation of the returned device identified that the stent was buckled.

• 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: 23888974
• Report Number: 2124215-2025-92969
• Device Sequence Number: 18554247
• Product Code: FAD
• UDI-Device Identifier: 08714729798989
• UDI-Public: (01)08714729798989
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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,Followup
• Report Date (Section B): 03/13/2026

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 Expiration Date: 02/14/2026
• Device Model Number: M006192142050
• Device Catalogue Number: M006192142050
• Device Lot Number: 0032901845
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 12/23/2025; 01/20/2026; 02/16/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 01/21/2026; 02/17/2026; 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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