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

Model Number M0061921330

Device Problems Break (1069); Deformation Due to Compressive Stress (2889)

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

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of stent shaft broken.Imdrf device code a040601 captures the reportable event of stent buckled material, inside the patent.

Event Description

It was reported to boston scientific corporation that a polaris ultra ureteral stent was used to treat kidney stones during a ureteroscopy procedure in the urinary tract, uterus and urethra.The procedure date was nor reported.During the procedure, there was a device malfunction.It was noted that the stent was found broken.The procedure was successfully completed with another polaris ultra ureteral stent.There were no patient complications reported as a result of this event.A photo of the complaint device was provided and showed that the stent shaft broken and buckled.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18636870
• MDR Text Key: 334550586
• Report Number: 2124215-2024-04492
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729124443
• UDI-Public: 08714729124443
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2024

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 Model Number: M0061921330
• Device Catalogue Number: 192-133
• Device Lot Number: 0032151491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2023
• 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