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

Model Number	M0061552320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name (b)(6).Device code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that a polaris loop ureteral stent was to be used during a lithotripsy procedure, and, during unpacking, it was noticed that the stent was fractured.The procedure was completed with another of the same device and there were no patient complications reported.
Event or Problem Description
It was reported that a polaris loop ureteral stent was to be used during a lithotripsy procedure, and, during unpacking, it was noticed that the stent was fractured.The procedure was completed with another of the same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block e1: initial reporter facility name.(b)(6) hospital.Block h6: device code a0401 captures the reportable event of stent shaft break.Upon receipt at our quality assurance laboratory, this polaris loop ureteral stent underwent a thorough analysis.Visual inspection of the device revealed that the stent shaft was detached in two parts.These parts were returned for analysis.Based on the information available and analysis results, the reported allegation of stent shaft break could be confirmed.It was possible to conclude that the issue could be caused by operational factors due to, the retrieval line may be removed before placement at the physician's discretion and if the retrieval line gets entangled in the coil and is removed using excess force, the stent can get detached/separated during the preparation affecting the performance of the device.A conclusion code of adverse event related to procedure was assigned to this investigation.

• Brand Name: POLARIS LOOP
• 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: 21106910
• Report Number: 2124215-2024-83112
• Device Sequence Number: 7947424
• Product Code: FAD
• UDI-Device Identifier: 08714729421085
• UDI-Public: 08714729421085
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030503
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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 Model Number: M0061552320
• Device Catalogue Number: M0061552320
• Device Lot Number: 0034038835
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 63 KG