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

Model Number	M0061921230
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	07/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a transuretheral ureteroscope laser lithotripsy procedure using a polaris ultra stent, it was noticed during preparation that the stent was broken into two pieces along the shaft.Another of the same stent was used to successfully complete the 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.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.Block h11: the polaris ultra ureteral stent has not been returned.However, there is one picture attached that shows one polaris ultra stent with the shaft detached, moreover, their suture and positioner are not visible.The reported event of stent shaft break was confirmed.It is possible to conclude that this issue could be caused by operational factors, the retrieval line may be removed before placement at the physician's discretion.If the retrieval line is removed using excess force, the stent can get detached 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 event occurred during the procedure and the device had no influence on the event.
Event or Problem Description
It was reported that, during a transuretheral ureteroscope laser lithotripsy procedure using a polaris ultra stent, it was noticed during preparation that the stent was broken into two pieces along the shaft.Another of the same stent was used to successfully complete the 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 a transuretheral ureteroscope laser lithotripsy procedure using a polaris ultra stent, it was noticed during preparation that the stent was broken into two pieces along the shaft.Another of the same stent was used to successfully complete the 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
Imdrf device code a0401 captures the reportable event of stent shaft break.The polaris ultra ureteral stent was returned for analysis.During visual and media inspection, the stent shaft was detached, and the suture hole was torn.Additionally, the suture and positioner were not returned.One photo attached showed that the stent shaft was detached.No other problems with the device were noted.The reported event of stent shaft break was confirmed.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, the retrieval line may be removed before placement at the physician's discretion.If the retrieval line is removed using excess force, the stent can get detached and torn 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 event occurred during the procedure and the device had no influence on event.

• 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: 19962754
• Report Number: 2124215-2024-49669
• Device Sequence Number: 8731975
• 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,Followup
• Report Date (Section B): 11/12/2024

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: M0061921230
• Device Catalogue Number: 192-123
• Device Lot Number: 0032938113
• 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: 07/17/2024
• Supplement Date Received by Manufacturer: 08/22/2024; 10/16/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/16/2024; 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2023
• 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