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

Model Number	M0061921320
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the cotton thread was entangled with the double j stent and the stent fractured during the removal of the thread.The procedure was completed with another of the same device and the patient condition following the procedure was stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.Block e1.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation results of stent shaft break.Block e1 address: (b)(6).Block h11: the polaris ultra ureteral stent was returned for analysis and the positioner returned in good condition.During the visual and magnification inspection, it was found that the renal coil fully detached.The reported event of stent shaft break will not be confirmed.However, after the device analysis, it was found the renal coil fully detached.This failure could have been caused due to an interaction of the device with the suture string such as entanglement, manipulation or excess of force applied over the device during procedure which consequently affects the performance of the device.Therefore, all compiled information on this investigation determines that the most probable cause is failure to follow instructions, since the problem found was traced to the user not following the manufacturer's instructions.
Event or Problem Description
It was reported that during the procedure, the cotton thread was entangled with the double j stent and the stent fractured during the removal of the thread.The procedure was completed with another of the same device and the patient condition following the procedure was stable.

• Brand Name: POLARIS ULTRA
• 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: 22215684
• Report Number: 2124215-2025-39291
• Device Sequence Number: 8131758
• Product Code: FAD
• UDI-Device Identifier: 08714729124429
• UDI-Public: (01)08714729124429(17)270402(10)33743216
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K010002
• 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): 07/25/2025

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: M0061921320
• Device Catalogue Number: M0061921320
• Device Lot Number: 0033743216
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• 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 Sex: Unknown