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

Model Number	M0061921410
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a stent placement procedure in the left proximal ureter, performed on (b)(6) 2021.On (b)(6) 2021, prior to the initial planned stent removal, while the patient was home complete distal migration occurred of the ureteral stent occurred.The polaris ultra stent was removed via retrieval line successfully with no difficulty on the same day.There was no report if a new stent was placed.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 stable.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a stent placement procedure in the left proximal ureter, performed on (b)(6) 2021.On (b)(6) 2021, prior to the initial planned stent removal, while the patient was home complete distal migration occurred of the ureteral stent occurred.The polaris ultra stent was removed via retrieval line successfully with no difficulty on the same day.There was no report if a new stent was placed.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 stable.Correction based on review on (b)(6) 2021 it was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a stent placement procedure in the left proximal ureter, performed on (b)(6) 2021 as part of the u0652 double-j registry clinical study.
Additional Manufacturer Narrative
Block h6: medical device problem code a010402 captures the reportable event of stent migration.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: correction to field b5 (describe event or problem).
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a stent placement procedure in the left proximal ureter, performed on (b)(6) 2021.On (b)(6) 2021, prior to the initial planned stent removal, while the patient was home complete distal migration occurred of the ureteral stent occurred.The polaris ultra stent was removed via retrieval line successfully with no difficulty on the same day.There was no report if a new stent was placed.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 stable.Correction based on review on april 06, 2021.It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a stent placement procedure in the left proximal ureter, performed on (b)(6) 2021 as part of the u0652 double-j registry clinical study.Additional information received on may 19, 2021.On (b)(6) 2021, prior to the initial planned stent removal, while the patient was home complete distal migration occurred of the ureteral stent during urination.Additionally the subject was reported to be asymptomatic.
Additional Manufacturer Narrative
Block h6: medical device problem code a010402 captures the reportable event of stent migration.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: POLARIS ULTRA
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11616454
• Report Number: 3005099803-2021-01464
• Device Sequence Number: 2998694
• Product Code: FAD
• UDI-Device Identifier: 08714729124528
• UDI-Public: 08714729124528
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2021

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: 09/01/2023
• Device Model Number: M0061921410
• Device Catalogue Number: 192-141
• Device Lot Number: 0025950849
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2021
• Supplement Date Received by Manufacturer: 04/06/2021; 05/19/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 04/06/2021; 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR