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

Model Number	M0061552310
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a0501 captures the reportable event of stent shaft break.The polaris loop ureteral stent has been returned.During the device and media analysis, it was found that the stent shaft and both loops detached.Additionally, the suturewas not returned.The reported event of stent shaft break was confirmed.It is possible to conclude that this 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 shaft and is removed using excess force, the stent can get detached 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 event.
Event or Problem Description
It was reported that, during preparation prior to transureteroscopic lithotripsy, it was noticed that the stent was fractured.Another of the same stent was used to successfully complete the procedure.No patient complications were reported.The condition of the patient at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: conclusion code 4316 is being used to capture that the event is no longer reportable.The polaris loop ureteral stent coil was clarified to be detached, occurred outside the patient, and determined that this event no longer meets reporting criteria.This event is now considered non reportable.
Event or Problem Description
It was reported that, during preparation prior to transureteroscopic lithotripsy, it was noticed that the stent was fractured.Another of the same stent was used to successfully complete the procedure.No patient complications were reported.The condition of the patient at the conclusion of the procedure was reported to be 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: 20533824
• Report Number: 2124215-2024-66114
• Device Sequence Number: 8465529
• Product Code: FAD
• UDI-Device Identifier: 08714729421078
• UDI-Public: 08714729421078
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/20/2025

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: 155-231
• Device Lot Number: 0033034207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• 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 Age: 56 YR
• Patient Sex: Female
• Patient Weight: 62 KG