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

Model Number	M0061552310
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the loop was entangled with cotton thread, causing it to break when being untied.The procedure was completed with another of the same device and the patient condition following procedure was stable.
Additional Manufacturer Narrative
Imdrf device code a0501 captures the reportable event of coil detachment of device, inside the patient.(b)(6).
Additional Manufacturer Narrative
Imdrf device code a0501 captures the reportable investigation results of coil detachment of device, inside the patient.The polaris loop ureteral stent was returned with the positioner for analysis, however, the suture did not return.During the device inspection under magnification, it was found that both loops detached in one section.The reported event of coil detachment of device will be confirmed.The retrieval line may be removed before placement at the physician's discretion.If the retrieval line gets entangled in the loops and is removed using excess force, the stent can get detached or separated during the preparation affecting the performance of the device.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 loop was entangled with cotton thread, causing it to break when being untied.The procedure was completed with another of the same device and the patient condition following procedure was stable.

• 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: 22555173
• Report Number: 2124215-2025-48057
• Device Sequence Number: 9559473
• Product Code: FAD
• UDI-Device Identifier: 08714729421078
• UDI-Public: (01)08714729421078(17)270604(10)34167187
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: M0061552310
• Device Catalogue Number: M0061552310
• Device Lot Number: 0034167187
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• 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