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

Model Number	M0061921420
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that there were some organic residues along the device.The suture hole was found torn and also the suture string was not returned for the analysis and also the positioner returned with the device.No other issues with the device were noted.The reported event was not confirmed.According to product analysis, it is possible that operational factors, such as interacting of the device with the suture string or other devices involved during procedure could have caused this failures.Once the suture hole is torn it is possible that an excess of force applied to the suture string during it used could damage it; consequently affect the performance of the device.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a retrograde intrarenal surgery procedure, performed on (b)(6) 2021.During introduction and inside the patient, it was noticed that the white part of the stent does not enter because it does not receive power.Another polaris ultra ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.This event has been deemed a reportable event based on the investigation finding of stent suture hole torn inside the patient.

• Brand Name: POLARIS ULTRA
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12448916
• Report Number: 3005099803-2021-04663
• Device Sequence Number: 3536743
• Product Code: FAD
• UDI-Device Identifier: 08714729124542
• UDI-Public: 08714729124542
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/09/2021

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: 11/04/2023
• Device Model Number: M0061921420
• Device Catalogue Number: 192-142
• Device Lot Number: 0026301828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 09/09/2021
• Patient Sequence Number: 1