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

Model Number	M0061921340
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter state/province: (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteral stenting procedure in the right ureter, performed on (b)(6) 2020.According to the complainant, during the procedure, inside the patient, the stent could not be inserted along with the ptfe guidewire.The pigtail was deformed by the pusher.The procedure was successfully completed with another polaris ultra 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 good.
Additional Manufacturer Narrative
Block e1: initial reporter state/province: (b)(6).Block h6: device code 2976 captures the reportable event of stent to material deformation inside the patient.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the bladder pigtail at the proximal section was buckled/cordoned.A functional evaluation noted that a mandrel 0.035" was inserted through the catheter and no resistance was felt, therefore, the issue related to difficult to advance was not confirmed.A photo was attached to the complaint record, it was analyzed and the catheter shows one bladder pigtail section buckled/accordion.No other issues with the device were noted.The reported event was confirmed.Based on product analysis, the bladder pigtail at the proximal section was buckled/cordoned.The investigation analysis concluded that the problem found is an issue that could have been generated due to the force used when the stent was pushed up with the pusher/positioner over the guidewire or when the stent was used.Moreover, the device was received without the suture string, evidence that the device was manipulated.It is the most likely that it was generated due to the manipulation of the device or due to the interaction with the other devices during the procedure.It is important to mention that during product analysis the device was tested and mandrel 0.035" were inserted through the catheter and no resistance was felt.Adverse event related to procedure is selected as the most probable root cause for the complaint since it is the most likely that the adverse event occurred during the procedure and the device had no influence on event.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 ureteral stenting procedure in the right ureter, performed on (b)(6) 2020.According to the complainant, during the procedure, inside the patient, the stent could not be inserted along with the ptfe guidewire.The pigtail was deformed by the pusher.The procedure was successfully completed with another polaris ultra 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 good.

• 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: 10868393
• Report Number: 3005099803-2020-05585
• Device Sequence Number: 11478773
• Product Code: FAD
• UDI-Device Identifier: 08714729124467
• UDI-Public: 08714729124467
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2020

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: 01/08/2023
• Device Model Number: M0061921340
• Device Catalogue Number: 192-134
• Device Lot Number: 0025013915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 12/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR