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

Model Number	M0061921310
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter state: (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 ureteroscopy procedure in the right ureter, performed on (b)(6) 2019.According to the complainant, during the procedure, outside the patient, when the physician pulled the suture from the bladder coil, it was noticed that the stent shaft broke.Another polaris ultra stent was opened and successfully completed the procedure.Photo of the complaint device was provided by the complainant and showed the coil deformed.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.
Event or Problem Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a ureteroscopy procedure in the right ureter, performed on (b)(6) 2019.According to the complainant, during the procedure, outside the patient, when the physician pulled the suture from the bladder coil, it was noticed that the stent shaft broke.Another polaris ultra stent was opened and successfully completed the procedure.Photo of the complaint device was provided by the complainant and showed the coil deformed.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: (b)(6).Block h6: device code 1069 captures the reportable event of stent shaft break.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the middle shaft of the stent was detached/separated.The bladder pigtail had several kinks and the tip was detached at suture hole section.The tip was not returned with the device.No other issues with the device were noted.The reported event was confirmed.The analysis of the returned device revealed that the stent shaft middle section was detached/separated, the bladder pigtail had several kinks, and the tip was detached at the suture hole section.Based on the product analysis, the stent was not returned with the suture string and the device was out of the original pouch; it is evidence that the stent was manipulated out of the package.Therefore, the problems found were issues that could have been generated by the user or due to the interacting of the device with the suture string or improper manipulation during procedure and preparation, moreover, the pigtail shows evidence of damages aligned to the suture string interaction and manipulation.Review and analysis of all available information indicated that the root cause is adverse event related to procedure.A complaint with a cause of adverse event related to procedure indicates that the adverse event occurred during the procedure and the device had no influence on the event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: 10885440
• Report Number: 3005099803-2020-05662
• Device Sequence Number: 2799390
• Product Code: FAD
• UDI-Device Identifier: 08714729124405
• UDI-Public: 08714729124405
• 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): 01/08/2021

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: 06/10/2022
• Device Model Number: M0061921310
• Device Catalogue Number: 192-131
• Device Lot Number: 0023933219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 01/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR