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

Model Number	M0061921320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
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 ureterolithotomy procedure in the ureter performed on (b)(6) 2024.During insertion, when the device was unpacked, the stent was found broken in two pieces.The procedure was successfully completed with another polaris ultra ureteral stent.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.A photo of the complaint device was provided and showed that the stent shaft was broken.
Additional Manufacturer Narrative
Block e1: initial reporter address: (b)(6).Block h6: imdrf device code: a0401 captures the reportable event of stent shaft broken.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was opened to be used during a ureterolithotomy procedure in the ureter performed on (b)(6) 2024.During insertion, when the device was unpacked, the stent was found broken in two pieces.The procedure was successfully completed with another polaris ultra ureteral stent.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.A photo of the complaint device was provided and showed that the stent shaft was broken.
Additional Manufacturer Narrative
Block e1: initial reporter address: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of stent shaft broken.Correction to block b3: date of 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: 18784913
• Report Number: 2124215-2024-09654
• Device Sequence Number: 8296816
• Product Code: FAD
• UDI-Device Identifier: 08714729124429
• UDI-Public: 08714729124429
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 03/25/2024

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: 07/13/2026
• Device Model Number: M0061921320
• Device Catalogue Number: 192-132
• Device Lot Number: 0032013382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2023
• 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: Female