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

Model Number	M0061921310
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a endoscopic combined intra renal surgery procedure in the urinary tract performed on (b)(6) 2022.During the procedure, it was noted that the stent could not be inserted through transurethral.The procedure was successfully completed with a different device.There were no patient complications reported as a result of this event.Investigation results revealed that the stent was buckled, inside the patient, therefore this event has been deemed an mdr reportable event.
Additional Manufacturer Narrative
Initial reporter city: (b)(6).Medical device code a0406 captures the reportable investigation results of stent buckled.The returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the stent became buckled accordion.Additionally, their suture and positioner were not returned.For the functional test, the stent passes through successfully and no resistance was felt.During magnification, it was observed closely that the stent was buckled accordion.Additionally, observed residues as part of the procedure.No other problems with the device were noted.The reported event was confirmed.There was no evidence from the manufacturing review to indicate that a device malfunctioned because of a process related defect.Most likely an interaction of the device with other device, manipulation such as operational factors could have contributed to the found issue.Regarding to the analysis performed to the returned device, evidence found with their bladder coil buckled accordion, additionally their suture was not returned, which means, that it was removed and indicates that the stent was used.This issue possible could be caused by operational factors, interaction of the device between the positioner and the guide wire while the device was used, such as excess of force applied over the device during the procedure could have contributed to the failure.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16375899
• Report Number: 3005099803-2023-00421
• Device Sequence Number: 14838689
• Product Code: FAD
• UDI-Device Identifier: 08714729124405
• UDI-Public: 08714729124405
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/14/2023

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: 12/09/2023
• Device Model Number: M0061921310
• Device Catalogue Number: 192-131
• Device Lot Number: 0026491269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2020
• 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