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

Model Number	M006192133010
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	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that during preparation, after unpacking the polaris ureteral stent it was found severed prior to lithotripsy procedure.No patient complications were reported.The condition of the patient at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported that during preparation, after unpacking the polaris ureteral stent it was found severed prior to lithotripsy procedure.No patient complications were reported.The condition of the patient at the conclusion of the procedure was reported to be stable.
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 returned for analysis.Also, a ureteral axxcess catheter and a guidewire was returned with the device.Additionally, the positioner did not return and the suture was returned cut and attached to the device.The reported event of stent shaft break was not confirmed and will be documented as no problem detected since there was no breakage on the stent shaft and this conclusion was selected because after visual and microscope inspections in the complaint device, it was not possible to identify any evidence of the alleged issue on the device since no detachment was observed on the stent shaft.However, there was evidence of stent coil detached or separated.Bladder coil and stent coil torn, due to the tears observed that could be related to what the customer reports by stent had been severed.It was possible to see that the bladder coil had some tears probably caused by the suture.Regarding to the analysis performed to the returned device, it is possible to conclude that this issue could be caused by operational factors.If the retrieval line gets entangled in the bladder coil and is removed using excess force, the stent can get detached or separated during the preparation affecting the performance of the device.Also, the force applied could have caused the tears observed on the bladder coil.For that reason, the issues of stent coil detached or separated and stent coil torn will be documented as adverse event related to procedure.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.

• 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: 20751549
• Report Number: 2124215-2024-73178
• Device Sequence Number: 4388733
• Product Code: FAD
• UDI-Device Identifier: 08714729779520
• UDI-Public: 08714729779520
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 01/09/2025

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: M006192133010
• Device Catalogue Number: M006192133010
• Device Lot Number: 0033674036
• 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: 10/30/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• 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