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

Model Number	M0061921330
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a polaris ultra ureteral stent was implanted into a patient during a flexible ureteroscopic lithotripsy procedure in the kidney.Two weeks following the procedure, it was found that the stent was fractured in the middle part and was left in the patient's body.The fractured piece was removed and another of the same device successfully completed the procedure.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was implanted into a patient during a flexible ureteroscopic lithotripsy procedure in the kidney.Two weeks following the procedure, it was found that the stent was fractured in the middle part and was left in the patient's body.The fractured piece was removed and another of the same device successfully completed the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Block h6: device code a0401 captures the reportable event of stent shaft break.Impact code f23 captures the reportable event of unexpected medical intervention.Block h11: investigation analysis: the complaint device was not returned therefore, product analysis could not be performed, for this reason and due to the lack of evidence is unable to confirm the reported event.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.A risk review was completed and confirmed that the event of \"stent shaft break\" was defined in the risk documentation.Based on the results of the device evaluation, an investigation conclusion code of unable to exclude device problem was assigned to this investigation.
Additional Manufacturer Narrative
Block e1: initial reporter facility name (b)(6).Block h6: device code a0401 captures the reportable event of stent shaft break.Impact code f23 captures the reportable event of unexpected medical intervention.
Additional Manufacturer Narrative
Block e1: initial reporter facility name\ (b)(6) hospital of (b)(6).\ block h6:\ device code a0401 captures the reportable event of stent shaft break.\ impact code f23 captures the reportable event of unexpected medical intervention.\ \ blocks b1, b2, and b5 has been corrected.\ \ block h11:\ investigation analysis:\ the complaint device was not returned therefore, product analysis could not be performed, for this reason and due to the lack of evidence is unable to confirm the reported event.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.A risk review was completed and confirmed that the event of \"stent shaft break\" was defined in the risk documentation.Based on the results of the device evaluation, an investigation conclusion code of unable to exclude device problem was assigned to this investigation.
Event or Problem Description
It was reported that a polaris ultra ureteral stent was implanted into a patient during a flexible ureteroscopic lithotripsy procedure in the kidney.Two weeks following the procedure, it was found that the stent was fractured in the middle part.The fractured piece was removed with the use of a pair of forceps and another of the same device 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 stable.

• 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: 24493054
• Report Number: 2124215-2026-11581
• Device Sequence Number: 10676347
• Product Code: FAD
• UDI-Device Identifier: 08714729124443
• UDI-Public: (01)08714729124443(17)280519(10)36564222
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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,Followup
• Report Date (Section B): 07/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0061921330
• Device Catalogue Number: M0061921330
• Device Lot Number: 0036564222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 03/09/2026; 06/05/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/06/2026; 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 171 LB