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

Model Number	M0061921220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date, 08/01/2024, was chosen as the best estimate based on the date that the manufacturer became aware of the event, 08/14/2024.Block h6: device problem code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was going to be used; however, the stent was found broken upon unpacking.Another of the same stent was used to successfully complete the procedure.No further patient complications were reported.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date, 08/01/2024, was chosen as the best estimate based on the date that the manufacturer became aware of the event, 08/14/2024.Block h6: device problem code a0401 captures the reportable event of stent shaft break.Block h11: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the shaft was detached.The suture and positioner were not returned.During a microscopic inspection, it was observed closely the shaft was detached and the suture hole torn.Therefore, the reported problem of stent shaft break is confirmed.Based on the most relevant information of the complaint event description, device analysis and 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.It is possible to conclude that this problem could be caused by operational factors.Additionally, 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 and torn during the preparation affecting the performance of the device.The event mentioned it occurred upon unpackaging, and the suture of the stent did not return indicating that it was removed, and the device was manipulated.Based on the analysis results, the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was going to be used; however, the stent was found broken upon unpacking.Another of the same stent was used to successfully complete the procedure.No further patient complications were 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: 20189811
• Report Number: 2124215-2024-56524
• Device Sequence Number: 7180137
• Product Code: FAD
• UDI-Device Identifier: 08714729124306
• UDI-Public: 08714729124306
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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: M0061921220
• Device Catalogue Number: 192-122
• Device Lot Number: 0033391057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• 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