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

Model Number	M0061552320
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	04/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a polaris loop ureteral stent was used in a hard ureteroscopic lithotomy procedure.During unpacking, it was found that the stent was fractured.The procedure was completed with another same device and there were no patient complications reported.Investigation of the returned device revealed that the stent shaft was detached/separated.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block e1: initial reporter facility name is (b)(6) hospital.Block h6: device code a0401 captures the reportable investigation result of stent shaft break.Upon receipt at our quality assurance laboratory, this polaris loop ureteral stent device underwent a thorough analysis.Visual analysis identified that both loops were detached (not fully).A part of the stent shaft near the loops was also fully detached and the loops were torn, probably caused by the suture.The suture was returned cut indicating it might have been removed from 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.Based on the information available and analysis results, it is possible to conclude that these issues 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 loops and is removed using excess force, the stent could get detached during the preparation affecting the performance of the device.The suture returned cut and not assembled in the device indicating that it might have been removed.The suture removal could have caused the detachment and tears observed on the loops and the detachment of part of the stent shaft.A conclusion code of adverse event related to procedure was assigned to this investigation.

• 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: 22516344
• Report Number: 2124215-2025-47095
• Device Sequence Number: 7951761
• Product Code: FAD
• UDI-Device Identifier: 08714729421085
• UDI-Public: (01)08714729421085(17)270702(10)34358714
• 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
• Report Date (Section B): 07/15/2025

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: 0034358714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• 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 Age: 52 YR
• Patient Sex: Male
• Patient Weight: 65 KG