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

Model Number	M0061921230
Medical Device Problem Codes	Break (1069); Defective Device (2588); Material Split, Cut or Torn (4008)
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 preparation, the polaris ultra ureteral stent was found creased.It was noticed after being used with the guidewire and after being pulled, the stent was found to be thinner and was fractured.The procedure was completed with another of the same stent.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
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 polaris ultra ureteral stent was return for analysis.During the microscope and visual inspection, during the inspection there was no problem and no damages detected in the device.Additionally, the suture did not return.The reported event of stent torn material, stent shaft break, and device damage defective will be not be confirmed.The device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.It was not possible also to identify any evidence of either the alleged issues or any defect on the device.Also, the evidence from the product record review did not identify a potential product quality issue or new patient harm.Therefore, all compiled information on this investigation is assigned a conclusion of no problem detected.
Event or Problem Description
It was reported that during preparation, the polaris ultra ureteral stent was found creased.It was noticed after being used with the guidewire and after being pulled, the stent was found to be thinner and was fractured.The procedure was completed with another of the same stent.The patient's condition following the procedure was reported to be 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: 20800528
• Report Number: 2124215-2024-74701
• Device Sequence Number: 7809782
• 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): 01/08/2025

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: 12/11/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/08/2025
• 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