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

Model Number	M0061921310
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation, when the package was opened, the polaris ultra ureteral stent was found broken.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 b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that during preparation, when the package was opened, the polaris ultra ureteral stent was found broken.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 b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.Block h11: the polaris ultra stent returned for analysis.During the inspection was found with the bladder coil detached.Additionally, the suture and positioner did not return.The detached part of the coil did not return.No other problems with the device were noted.The reported event of stent shaft break was not confirmed since the reported issue was not detected during the analysis.But instead the inspection found the stent with the bladder coil detached.It is possible to concluded 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 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: 20285800
• Report Number: 2124215-2024-58108
• Device Sequence Number: 18145834
• Product Code: FAD
• UDI-Device Identifier: 08714729124405
• UDI-Public: 08714729124405
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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: M0061921310
• Device Catalogue Number: M0061921310
• Device Lot Number: 0033460304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2024
• 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