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

Model Number	M0061921320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an endoscopic ureterolithotomy procedure; while attempting to insert a double-j catheter, we noticed a problem.The device comes with a protective plastic cover that must be removed before insertion.This plastic was tangled with the catheter wires, and when we tried to remove it, it broke into two pieces.This incident occurred in the operating room during the procedure.The integrity of the product was compromised during handling prior to insertion.The procedure was completed with another of the same device and there were no known patient complications reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.Block h11: the returned polaris ureteral stent was analyzed, and during the inspection, it was found that the shaft was detached into two parts and the suture hole was torn up to the tip; this condition was confirmed through visual and microscopic inspection and supported by the media provided by the customer.Based on the available information, the device analysis including the product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.Regarding to the analysis performed to the returned device, it is possible to conclude that this problem 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 or separated during the procedure affecting the performance of the device.Based on the investigation analysis results, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported that during an endoscopic ureterolithotomy procedure, while attempting to insert a double-j catheter, we noticed a problem.The device comes with a protective plastic cover that must be removed before insertion.This plastic was tangled with the catheter wires, and when we tried to remove it, it broke into two pieces.This incident occurred in the operating room during the procedure.The integrity of the product was compromised during handling prior to insertion.The procedure was completed with another of the same device and there were no known patient complications reported.

• 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: 22821425
• Report Number: 2124215-2025-55169
• Device Sequence Number: 9750324
• Product Code: FAD
• UDI-Device Identifier: 08714729124429
• UDI-Public: (01)08714729124429(17)280212(10)35840797
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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: 0035840797
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2025
• 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: 43 YR
• Patient Sex: Female
• Patient Weight: 64 KG