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

Model Number	M0061921320
Medical Device Problem Codes	Nonstandard Device (1420); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of coil detached inside the patient.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was used during a flexible ureteroscopic lithotripsy procedure in the kidney.During the procedure and inside the patient, it was noticed that the stent was fractured.The procedure was completed with another of the same device and there were no patient complications reported.The patient's condition following the procedure was reported to be stable.A photo of the complaint device was provided and showed that the coil was detached.
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of coil detached inside the patient.Impact code f23 captures the reportable event unexpected medical intervention.Blocks b2, b5, h1 and h6, have been updated based on the additional information received on march 25, 2026.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was used during a flexible ureteroscopic lithotripsy procedure in the kidney.During the procedure and inside the patient, it was noticed that the stent was fractured.The procedure was completed with another of the same device and there were no patient complications reported.The patient's condition following the procedure was reported to be stable.A photo of the complaint device was provided and showed that the coil was detached.Additional information was received stating that the broken stent was removed from the patient using a pair of forceps.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was used during a flexible ureteroscopic lithotripsy procedure in the kidney.During the procedure and inside the patient, it was noticed that the stent was fractured.The procedure was completed with another of the same device and there were no patient complications reported.The patient's condition following the procedure was reported to be stable.A photo of the complaint device was provided and showed that the coil was detached.The broken stent was removed from the patient with the use of forceps.
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of coil detached inside the patient.Impact code f23 captures the reportable event unexpected medical intervention.Block h11: the returned polaris ultra ureteral stent was analyzed, and during the inspection, it was found that the bladder coil detached and the suture hole torn until the tip.The device was inspected under magnification, and it was possible to see the bladder coil detached and the suture hole torn until the tip being able to confirm the reported event.Based on the information available and analysis results, it is possible to conclude that this problem could be caused by operational factors.The retrieval line may be removed before placement at the physician's discretion.If the retrieval line gets entangled in the bladder coil and is removed using excess force, the stent can get "detached/separated" and "torn" during the preparation affecting the performance of the device.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.A risk review was completed and confirmed that the events of "detachment of device or device component" and " were defined in the risk documentation.These events type have been accounted during product risk analysis to support acceptable risk benefits for the product.Therefore, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.

• 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: 24688698
• Report Number: 2124215-2026-16299
• Device Sequence Number: 10004223
• Product Code: FAD
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/29/2026

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: M0061921320
• Device Catalogue Number: M0061921320
• Device Lot Number: 0034796246
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 03/25/2026; 04/30/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/22/2026; 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 198 LB