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

Model Number	M0061552320
Medical Device Problem Codes	Defective Device (2588); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a polaris loop ureteral stent was used in a ureteroscopic lithotripsy procedure.During the procedure while in the patient, the loop was entangled to the suture string causing it to break when being untied.The procedure was completed with another of the same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable investigation results of stent torn material.
Additional Manufacturer Narrative
The reported lot number could not be matched to the reported device upn.Therefore, the lot expiration and device manufacture dates are unknown at this time.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.Imdrf device code a0414 captures the reportable investigation results of stent torn material.Investigation analysis: upon receipt at our quality assurance laboratory, this polaris loop ureteral stent underwent a thorough analysis.Visual analysis identified that the stent renal coil was torn.The suture and positioner were 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 the issue 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 renal coil and is removed using excess force, the stent can get torn during the preparation affecting the performance of the device.A conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that a polaris loop ureteral stent was used in a ureteroscopic lithotripsy procedure.During the procedure while in the patient, the loop was entangled to the suture string causing it to break when being untied.The procedure was completed with another of the same device and there were no patient complications reported.

• 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: 23490436
• Report Number: 2124215-2025-80469
• Device Sequence Number: 4758343
• Product Code: FAD
• UDI-Device Identifier: 08714729421085
• UDI-Public: (01)08714729421085
• 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): 12/26/2025

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: M0061552320
• Device Catalogue Number: M0061552320
• Device Lot Number: 360108637
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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