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

Model Number	M0061921230
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the ureteroscopic lithotripsy procedure, the polaris ultra ureteral stent was found with creases, inside the patient.The procedure was completed with another of the same device.The patient's condition following the procedure was stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent kinked, inside the patient.
Additional Manufacturer Narrative
H6: imdrf device code a0406 captures the reportable event of stent kinked, inside the patient.The reported event of stent kinked will not be confirmed and will be documented as no problem detected.This conclusion was selected because after visual and microscope inspection in the complaint device, it was not possible to identify any evidence of the alleged issue on the device since no important kinks were observed on the stent.However, the stent was found with the positioner bent and bladder coil detached or separated.Regarding to the analysis performed to the returned device, it is possible to conclude that these issues could be caused by operational factors.According to the task analysis of the product, the retrieval line may be removed before placement at the physician's discretion.If the retrieval line gets entangled in the bladder coil and is removed using excess force, the stent can get detached or separated and could lead to bend the positioner 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 events occurred during the procedure and the device had no influence on the events.
Event or Problem Description
It was reported that during the ureteroscopic lithotripsy procedure, the polaris ultra ureteral stent was found with creases, inside the patient.The procedure was completed with another of the same device.The patient's 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: 20799362
• Report Number: 2124215-2024-74731
• Device Sequence Number: 6754907
• Product Code: FAD
• UDI-Device Identifier: 08714729124320
• UDI-Public: 08714729124320
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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: M0061921230
• Device Catalogue Number: M0061921230
• Device Lot Number: 0033294650
• 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: 11/04/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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