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

Model Number	M0061921220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a0401captures the reportable event of stent shaft broken.
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a lithotripsy by flexible ureteroscopy procedure in the left ureter performed on (b)(6) 2023.During unpacking, it was found that the middle part of the stent was fractured.The procedure was successfully completed with another polaris loop 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.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a stent placement in the kidney for kidney stones performed on (b)(6) 2023.During unpacking, it was found that the middle part of the stent was fractured.The procedure was successfully completed with another polaris loop 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.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401captures the reportable event of stent shaft broken.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the stent shaft was detached.Additionally, the suture and positioner were not returned.A functional evaluation noted that a mandrel 0.035" passed through the stent without resistance.During the microscope inspection, it was observed closely that the stent shaft was detached and the suture hole was in good condition.No other problems with the device were noted.The reported event was confirmed.Based on the product analysis performed, it was found that the stent shaft was detached.Additionally, the suture was not returned, indicating that it was removed, and the stent was used, evidence that it is possible that operational factors interacting with excess force during interaction with the suture string such as an entanglement and/or a tension generated at the time of removing the suture before its use could have caused the detachment.Consequently, affecting the performance of the device.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.Block h11: block b5 procedure name and anatomy location has been corrected.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16448694
• Report Number: 3005099803-2023-00965
• Device Sequence Number: 14806846
• Product Code: FAD
• UDI-Device Identifier: 08714729124306
• UDI-Public: 08714729124306
• 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
• Report Date (Section B): 03/27/2023

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: 06/15/2024
• Device Model Number: M0061921220
• Device Catalogue Number: 192-122
• Device Lot Number: 0027507084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2023
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2021
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 56 KG