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

Model Number	M006193122090
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was opened to be used during a ureteral stent placement procedure in the kidney to bladder to urinary tract performed on (b)(6) 2023.During the procedure, when the package was opened, the sensor wire attached to the stent was found broken.The procedure was successfully completed with another guidewire device.There were no patient complications reported as a result of this event.Investigation results revealed that the sleeve was detached/separated, therefore this event has been deemed an mdr reportable event.Please see block h10 for full investigation details.
Additional Manufacturer Narrative
H6: imdrf device code a0401 captures the reportable investigation results of sleeve detached/separated.H10: the returned sensor guide wire was analyzed, and a visual evaluation noted that the sleeve detached, however, the part was not returned with the device.Due to these conditions, the reported complaint could not be confirmed.No other problems with the device were noted.The reported event of tip detached was not confirmed.Taking all available information into consideration, most likely, the device met all the manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.Based on the analysis, it is most likely that as part of the device manipulation during the procedure, an excess of force was applied to the device such as during the guidewire insertion through another device or the interaction with the scope, causing the sleeve detached.This event will be assigned a code of adverse event related to procedure.The reported problem of guide wire tip detached was not confirmed since it was not detected during the analysis and therefore, the analyze code will be no problem detected.The most probable cause of this complaint is adverse event related to procedure since it is most likely that 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: 18432054
• Report Number: 2124215-2023-73741
• Device Sequence Number: 8173856
• Product Code: FAD
• UDI-Device Identifier: 08714729762850
• UDI-Public: 08714729762850
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 01/02/2024

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 Expiration Date: 03/08/2024
• Device Model Number: M006193122090
• Device Catalogue Number: 193-122-09
• Device Lot Number: 0031039521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2021
• 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