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

Model Number M0061552320

Device Problems Calcified (1077); Difficult to Remove (1528); Obstruction of Flow (2423)

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

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The returned polaris loop ureteral stent was analyzed, and a visual evaluation noted that the distal section was calcified.A functional evaluation noted that the distal section was calcified.No other issues with the device were noted.The reported event was confirmed.According to product analysis, the device was calcified along the distal section and was occluded due to the calcification present in the stent.The problems found are condition that will affect the device performance.It is important to mention that the device does not present any section torn or detached.Therefore, known inherent risk of device 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.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that a polaris loop ureteral stent was used during a ureteral lithotomy under flexible ureteroscopic procedure in the kidney, performed on an unknown date.A stent removal procedure was performed on (b)(6) 2021, during the procedure, when the physician attempted to remove the stent, there was difficulty in removing.This was observed under a rigid ureteroscopic and took a lot of time to remove the stent tube.The stent was pulled out and was removed in its entirely.Another polaris loop ureteral stent was implanted 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.

• Brand Name: POLARIS LOOP
• 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: 12288284
• MDR Text Key: 265405121
• Report Number: 3005099803-2021-03869
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729421085
• UDI-Public: 08714729421085
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/06/2021

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: 02/23/2023
• Device Model Number: M0061552320
• Device Catalogue Number: 155-232
• Device Lot Number: 0025254364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 08/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2020
• 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: 41 YR
• Patient Weight: 70