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

Model Number	M0061552320
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	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the doctor was about to place the dj inside the patient's body, but after the placement, he found that the coil at the end was broken.The procedure was completed with another of the same device.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of coil detachment of device or device component, inside the patient.
Event or Problem Description
It was reported that during the procedure, the doctor was about to place the dj inside the patient's body, but after the placement, he found that the coil at the end was broken.The procedure was completed with another of the same device.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable investigation results of coil detachment of device or device component, inside the patient.Block h11: the polaris loop was returned for analysis.The reported event of coil detachment of device or device component will be confirmed.During visual and magnification inspection, it was found that both loops were detached, not fully.The suture did not return assembled in the device, indicating it might have been removed.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 without being gently, the stent can get detached during procedure 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.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable investigation results of coil detachment of device or device component, inside the patient.Correction to block b5.The polaris loop ureteral stent coil was clarified to be detached that occurred outside the patient.Therefore, this determined that the event no longer meets reporting criteria.This event is now considered non-reportable.
Event or Problem Description
It was reported that during the ureteroscopic lithotripsy procedure, the physician was about to place the polaris loop ureteral stent inside the patient's body, but after the placement, he found that the coil at the end was broken.The procedure was completed with another of the same device and the patient condition after the procedure was good.

• 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: 21971951
• Report Number: 2124215-2025-27692
• Device Sequence Number: 8692036
• Product Code: FAD
• UDI-Device Identifier: 08714729421085
• UDI-Public: (01)08714729421085(17)260801(10)32136115
• 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,Followup
• Report Date (Section B): 08/28/2025

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 Expiration Date: 08/01/2026
• Device Model Number: M0061552320
• Device Catalogue Number: M0061552320
• Device Lot Number: 0032136115
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 06/05/2025; 08/06/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/30/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2023
• 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 Sex: Unknown