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

Model Number	M0061921230
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) hospital.Block h6: imdrf device code captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that, during a ureteroscopic lithotripsy procedure using a polaris ultra ureteral stent, the stent body was ruptured.Another of the same device was used to complete the procedure.No patient complications were reported.
Event or Problem Description
It was reported that, during a ureteroscopic lithotripsy procedure using a polaris ultra ureteral stent, the stent was torn.Another of the same device was used to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Block h6: imdrf device code a0414captures the reportable event of stent torn.Block h11: additional information to field block b5 (describe event or problem) correction to field block h6: device code.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Block h6: imdrf device code a0414captures the reportable event of stent torn.Block h11: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation observed deformation of the drainage holes and tears in the renal coil.Was likely caused by operational factors during the procedure.Based on the task analysis, the retrieval line, which can be removed at the physician's discretion before placement, may have become entangled with the renal coil.If excessive force was applied to remove this line, it could have caused the observed tear to the stent.Moreover, the suture, which did not return with the device, further supports the idea that forceful removal of the suture may have contributed to the tear in the renal coil and deformation of the drainage holes.As a result, the most probable cause is adverse event related to procedure was assigned to this investigation.Correction to field block d4 (catalog number).
Event or Problem Description
It was reported that, during a ureteroscopic lithotripsy procedure using a polaris ultra ureteral stent, the stent body was ruptured.Another of the same device was used to complete the procedure.No patient complications were reported.

• 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: 20748221
• Report Number: 2124215-2024-72602
• Device Sequence Number: 8287782
• Product Code: FAD
• UDI-Device Identifier: 08714729124320
• UDI-Public: 08714729124320
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 01/13/2025

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: 01/25/2026
• Device Model Number: M0061921230
• Device Catalogue Number: M0061921230
• Device Lot Number: 0030931265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 11/26/2024; 12/20/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 12/19/2024; 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2023
• 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: Unknown