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

Model Number M0061921320

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).The polaris ultra ureteral stent was not returned for analysis, however, a photo attached revealed a stent with the shaft section detached, the section detached was not observed in the picture and the picture showed a part of another device damaged.It is important to mention that the picture are not very clear.The reported event was confirmed.The reported problems could have been caused by an excess of force during advancing the stent and withdrawal as well, also the technique of the physician and the anatomy could contributed without a proper activation of the coating in the guidewire may have generated the damage affecting the performance of the device.Based on the information provided, the most probable cause of the reported issue cannot be established due to lack of evidence.Additionally, without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Therefore, cause not establish 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 Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a flexible laser ureteroscopy procedure in the kidney, performed on (b)(6) 2021.During the procedure, when the physician attempted to deploy the stent, the guidewire was difficult to remove and the guidewire remained inside the ureteral stent.When the device was removed, it was noticed that a part of the gidewire remained inside the stent.Another polaris ultra ureteral stent was opened and successfully completed the procedure.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.A photo of the complaint device was provided and showed that the stent shaft was broken.

• Brand Name: POLARIS ULTRA
• Type of Device: 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: 12494732
• MDR Text Key: 272121224
• Report Number: 3005099803-2021-04913
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124429
• UDI-Public: 08714729124429
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K010002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/20/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2024
• Device Model Number: M0061921320
• Device Catalogue Number: 192-132
• Device Lot Number: 0026664135
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR