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

Model Number	M0061921420
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a cencer procedure in the ureter, performed on (b)(6) 2021.During the procedure, the stent was difficult to insert through the guidewire and it was noticed that the inner hole of the stent was kinked.Another polaris ultra ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.A photo of the complaint device was provided and showed that one of the end of the stent coil was kinked.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Block h6: medical device problem code a0406 captures the reportable event of stent kinked inside the patient.Block h10: the returned polaris ultra ureteral stent was analyzed, however, there is one picture attached in the complaint record and the photo was provided in the complaint record, was possible observe the stent bladder and renal pig tail in a good shape.During the visual inspection was noted the device in a good shape.The returned device matches with upn provided by the customer.No other issues with the device were noted.The reported event was not 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.After functional, visual, test in the complaint device it was not possible to identify any evidence of either the alleged issues or any defect on the device.Also, the evidence from the product record review did not identify a potential product quality issue or new patient harm.Therefore, no problem detected is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a cencer procedure in the ureter, performed on (b)(6) 2021.During the procedure, the stent was difficult to insert hrough the guidewire and it was noticed that the inner hole of the stent was kinked.Another polaris ultra ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.A photo of the complaint device was provided and showed that one of the end of the stent coil was kinked.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13020557
• Report Number: 3005099803-2021-07435
• Device Sequence Number: 4704454
• Product Code: FAD
• UDI-Device Identifier: 08714729124542
• UDI-Public: 08714729124542
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 02/04/2022

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: 01/29/2024
• Device Model Number: M0061921420
• Device Catalogue Number: 192-142
• Device Lot Number: 0026720774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2021
• 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 Age: 49 YR
• Patient Sex: Male